Detailed clinical ng i s s eoc pr ons i t uc r nst i

Clinical Processing of Cutting Tools. Instructions for cleaning and sterilizing saw blades, drills and burrs.

Detailed clinical processing instructions

This publication is not intended for distribution in the USA.

Instruments and implantsapproved by the AO Foundation.

Clinical processing of Cutting Tools DePuy Synthes 1

Table of Contents

General Information 2

Cleaning and Sterilization Instructions In general 4

Cleaning instruction 5

Inspection and function control 8

Packaging 9

Sterilization 9

Storage 10

Ordering Information 11

2 DePuy Synthes Clinical processing of Cutting Tools

General Information

Clinical processing of cutting toolsSynthes recommends using new, sterile cutting tools for each operation and discarding them after use. This prevents health risks to the patient and hospital personnel.

Certain cutting tools may be processed several times (see the list at the end of the instructions); however, cutting tools are frequently exposed to high mechanical loads and shocks during use and should not be expected to last indefinitely. Proper handling and maintenance help extend the useful life of surgical instruments.

Important The clinical processing instructions provided have been vali-dated by Synthes for preparing a non-sterile Synthes medical device; this instruction is provided in accordance with ISO 17664. It remains the responsibility of the processor to ensure that the processing performed achieves the desired result using the appropriate properly installed, maintained, and validated equipment, materials, and personnel in the processing unit. Any deviation by the processor from the in-structions provided should be properly evaluated for effec-tiveness and potential adverse consequences.

Additional InformationRefer to product-specific literature for clinical processing of power tools and attachments. Consult national regulations and guidelines for additional information. Compliance is ad-ditionally required with internal hospital policies and proce-dures and recommendations of manufacturers of detergents, disinfectants, and any clinical processing equipment.

Sterile-packaged saw blade


Microscopic view of a diamond-coated burr with bone residue

Warning – Special caution must be taken with cutting tools due to

the danger of injury and infection. – Diamond burrs and cutting tools made of hard metal (car-

bide) cannot be reprocessed since diamond burrs cannot be cleaned properly, and the latter can break if used several times. They must therefore be discarded after each use.

– Damaged, blunt or otherwise non-functional cutting tools must be disposed of and may not be reused.

Unusual Transmissible PathogensSurgical patients identified as at-risk for Creutzfeldt-Jakob disease (CJD) and related infections should be treated with single-use instruments. Dispose of instruments used or suspected of use on a patient with CJD after surgery accord-ing to internal hospital policies and procedures and/or current national recommendations.

Restrictions on clinical processing – For each operation we recommend using a new Synthes

original cutting tool. Cutting tools must be cooled with ir-rigation liquid to prevent heat necrosis.

– Wear from use or unintentionally cutting metal (such as metal protective sleeves or forceps) reduces the life of cutting tools. The probable life of cutting tools therefore cannot be estimated.

– Blunt or damaged tools that are reused can generate ex-cess heat and cause necrosis. Cuts made with a damaged saw blade can be imprecise, and osteosynthesis may be dissatisfactory. The function of each tool must be thor-oughly checked each time after it is cleaned and be re-placed if necessary.

– Resharpening of blunt cutting tools is not possible. Microscopic view of a damaged saw blade


1In generalSynthes products supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Prior to cleaning, remove all original packaging. Clean products be-fore first and every use. Prior to steam sterilization, place the product in an approved wrap or container.

The first and most important step in decontaminating all re-usable instruments is thorough (manual and/or mechanical) cleaning and rinsing. Thorough cleaning is a complex process whose success depends on various interrelated factors: Water quality, quantity and type of cleaning agent, cleaning method (manual, ultrasonic bath, washer/disinfector), thor-ough rinsing and drying, proper product preparation, time, temperature, and thoroughness of the individual responsible for cleaning.

Residual organic matter may reduce the effectiveness of the sterilization process.

Synthes recommends enzymatic detergents cleaners with pH 7–9.5. The use of cleaners with higher pH-values can – depending on the cleaner – cause a dissolution of the sur-face of aluminum, titanium, its alloys, plastics or compound materials. At pH-values higher than 11 also the surfaces of stainless steel can be affected. For detailed information about material compatibility, see “Material Compatibility of Synthes Instruments in Clinical Processing“ at www.synthes.com/reprocessing.

Synthes used the following cleaning agents during valida tion of these reprocessing recommendations. These cleaning agents are not listed in preference to other available cleaning agents which may perform satisfactorily – neutral pH enzy-matic detergents (e.g. Steris® Prolystica 2X Concentrate Enzy-matic Cleaner) and alkaline pH detergents (e.g. Neodisher® MediClean Forte).

Cleaning and Sterilization Instructions


2Cleaning instructionClean and sterilize instruments as soon as possible after use. Before cleaning remove all cutting tools from the power tool and attachments.

To prevent injury, remove pointed or sharp instruments, which must be manually cleaned, and place them in a sepa-rate tray.

Enzymatic cleaners with a pH 7– 9.5 are recommended. Alkaline detergents with a pH <11 may also be used.

Follow the detergent manufacturer’s instructions for use for correct dilution concentration, temperature, exposure time, and water quality. If temperature and time not provided, fol-low Synthes recommendations. Devices should be cleaned in a fresh, newly-made solution. Do not use abrasive cleaning devices, e.g., steel wool or abrasive cleaners, on Synthes devices.

Whenever possible, a washer/disinfector (according to ISO 15883) should be used for cutting tools. Prevent overloading of wash baskets for washer/disinfector. Care must be taken that the cutting tools do not come in contact with one an-other as this may result in damage to the tools.Unless other-wise noted, Synthes recommends cleaning non-sterile de-vices by performing the following process steps:a. Manual cleaning and/orb. Automated cleaning with manual pre-cleaning


Step Duration (minimum) Cleaning Instructions

1 2 minutes Rinse soiled device under running cold deionized, distilled or purified water to loosen soil. Remove gross soil by manipulating moving parts and using of soft bristled brush or clean, soft, lint-free cloth.

2 2 minutes Fully immerse device in freshly prepared pH neutral enzymatic or alkaline cleaner and manually agitate. Manipulate moving parts several times to ensure exposure to detergent. Use a sponge, soft lint-free cloths or soft bristle brush to remove all visible soil.

3 2 minutes Rinse device thoroughly with deionized, distilled or purified water. Use a syringe, pipette or water pistol to flush lumens and channels. Manipulate moving parts.

4 Visually inspect device. Repeat the manual cleaning procedure until no visible soil remains on device.

5 Dry device using a clean, soft, lint-free cloth or clean compressed air.


Pre-cleaning method


1 2 minutes Rinse soiled device under running cold deionized, distilled or purified water to loosen soil. Remove gross soil by manipulating moving parts and using of soft bristled brush or clean, soft, lint-free cloth.

2 2 minutes Fully immerse device in freshly prepared pH neutral enzymatic or alkaline cleaner and manually agitate. Manipulate moving parts several times to ensure exposure to detergent. Use a sponge, soft lint-free cloths or soft bristle brush to remove all visible soil.

3 2 minutes Rinse device thoroughly with deionized, distilled or purified water. Use a syringe, pipette or water pistol to flush lumens and channels. Manipulate moving parts.

4 Visually inspect device. Repeat the manual cleaning procedure until no visible soil remains on device.

5 Dry device using a clean, soft, lint-free cloth or clean compressed air.

a) Manual cleaning

b) Automated cleaning with manual pre-cleaning


Note: The washer/disinfector should fulfill requirements specified in ISO 15883.

Automated cleaning method


Rinse 2 minutes Cold deionized (DI) or purified water (PURW)

Pre-wash 1 minute Warm DI or PURW water (≥40°C); use detergent

Clean 2 minutes Warm DI or PURW water (≥45°C); use detergent

Neutralize 2 minutes Warm DI or PURW water with neutralizer, if necessary

Rinse 5 minutes Rinse with deionized (DI) or purified water (PURW)

Thermal Desinfection

5 minutes Hot DI water, ≥90°C

Dry 40 minutes ≥ 90°C


3Inspection and function controlBefore the cleaned products are packaged and sterilized, carefully examine them with a microscope or magnifying glass (minimum enlargement of 1:10) to see if they are clean, undamaged and function properly. Repeat cleaning steps until no visible soil remains on device.

Check instruments for sound surfaces and function. Do not use severely damaged instruments, instruments with un-recognizable markings, corrosion, or blunt cutting surfaces. Resharpening of blunt cutting tools is not possible.

Microscopic view of an unused burr

Microscopic view of a cleaned, used drill bit with residue and mechanical damage

Microscopic view of a cleaned, used burr with residue and mechanical damage

Microscopic view of an unused drill bit

Microscopic view of a cleaned, used saw blade with residue and mechanical damage

Microscopic view of an unused saw blade



Dry times generally range from 20 to 60 minutes due to dif-ferences in packaging materials (Sterile Barrier System, e.g., wraps or re-usable rigid container systems), steam qual-ity, device materials, total mass, sterilizer performance, and varying cool-down time.

The distributor and manufacturer accept no responsibility for sterilization procedures performed by the customer that are not performed according to these Synthes recommenda-tions.

4PackagingPut cleaned, dry products into the proper places in the Synthes case. Additionally, use an appropriate sterilization wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier System according to ISO 11607. Care should be taken to protect implants, and pointed and sharp instruments from contact with other objects that may dam-age the surface or the Sterile Barrier System.

5SterilizationIf not otherwise specified, non-sterile products may be re-sterilized using validated steam sterilization methods (ISO 17665 or national standards). Synthes recommendations for packed cutting tools are as follows.

Cycle type Sterilization exposure time

Sterilization exposure temperature

Dry time

Saturated steam-forced air removal (pre-vacuum) (minimum 3 pulses)

Minimum 4 minutes Minimum 132°CMaximum 138°C

20 – 60 minutes

Minimum 3 minutes Minimum 134°CMaximum 138°C

20 – 60 minutes


6StorageStorage conditions for products labeled “STERILE” are printed on the packaging label. Packaged products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity. Use products in the order in which they are received (“first-in, first-out principle“), taking note of any expiration date on the label.



The following cutting tools can be clinical processed using the above-described method:

03.000.000 Burr, round, S, B 1.0 mm

03.000.001 Burr, round, M, B 1.0 mm

03.000.002 Burr, round, L, B 1.0 mm

03.000.003 Burr, round, S, B 1.5 mm

03.000.004 Burr, round, M, B 1.5 mm

03.000.005 Burr, round, L, B 1.5 mm

03.000.006 Burr, round, S, B 2.5 mm

03.000.007 Burr, round, M, B 2.5 mm

03.000.008 Burr, round, L, B 2.5 mm

03.000.009 Burr, round, S, B 3.0 mm

03.000.010 Burr, round, M, B 3.0 mm

03.000.011 Burr, round, L, B 3.0 mm

03.000.012 Burr, round, S, B 4.0 mm

03.000.013 Burr, round, M, B 4.0 mm

03.000.014 Burr, round, L, B 4.0 mm

03.000.015 Burr, round, S, B 5.0 mm

03.000.016 Burr, round, M, B 5.0 mm

03.000.017 Burr, round, L, B 5.0 mm

03.000.018 Burr, round, S, B 6.5 mm

03.000.019 Burr, round, M, B 6.5 mm

03.000.020 Burr, round, L, B 6.5 mm

03.000.021 Burr, round, S, B 8.0 mm

03.000.022 Burr, round, M, B 8.0 mm

03.000.023 Burr, round, L, B 8.0 mm

03.000.060 Burr, acorn-shaped, S, B 6.0 mm, head length 8.0 mm

03.000.061 Burr, acorn-shaped, M, B 6.0 mm, head length 8.0 mm

03.000.062 Burr, acorn-shaped, L, B 6.0 mm, head length 8.0 mm







03.000.070 Burr, egg-shaped, S, B 4.0 mm, head length 8.0 mm

03.000.071 Burr, egg-shaped, M, B 4.0 mm, head length 8.0 mm

03.000.072 Burr, egg-shaped, L, B 4.0 mm, head length 8.0 mm

03.000.073 Burr, egg-shaped, S, B 5.5 mm, head length 10 mm

03.000.074 Burr, egg-shaped, M, B 5.5 mm, head length 10 mm

03.000.075 Burr, egg-shaped, L, B 5.5 mm, head length 10 mm

03.000.076 Burr, pear-shaped, S, B 5.0 mm, head length 8.3 mm

03.000.077 Burr, pear-shaped, M, B 5.0 mm, head length 8.3 mm

Ordering Information

All cutting tools are also available sterile packed. Add suffix “S“ to article number.

03.000.078 Burr, pear-shaped, L, B 5.0 mm, head length 8.3 mm




03.000.082 Burr, barrel-shaped, S, B 5.0 mm, head length 10 mm

03.000.083 Burr, barrel-shaped, M, B 5.0 mm, head length 10 mm

03.000.084 Burr, barrel-shaped, L, B 5.0 mm, head length 10 mm

03.000.100 Burr, inverted cone, S, B 6.5 mm, head length 6.1 mm

03.000.101 Burr, inverted cone, M, B 6.5 mm, head length 6.1 mm

03.000.102 Burr, inverted cone, L, B 6.5 mm, head length 6.1 mm

03.000.103 Burr, drum-shaped, S, B 6.0 mm, head length 7.9 mm

03.000.104 Burr, drum-shaped, M, B 6.0 mm, head length 7.9 mm

03.000.105 Burr, drum-shaped, L, B 6.0 mm, head length 7.9 mm




03.000.112 Lindemann Reamer, S, B 2.3 mm, head length 20.2 mm

03.000.113 Lindemann Reamer, M, B 2.3 mm, head length 20.2 mm

03.000.114 Lindemann Reamer, L, B 2.3 mm, head length 20.2 mm

03.000.115 Swanson Burr, S, B 2.0 mm, head length 6.3 mm

03.000.116 Swanson Burr, M, B 2.0 mm, head length 6.3 mm

03.000.117 Swanson Burr, L, B 2.0 mm, head length 6.3 mm







03.000.124 Burr, cranial, S, B 1.8 mm, head length 11 mm, for Craniotome No. 05.001.051

03.000.125 Burr, cranial, M, B 2.2 mm, head length 16 mm, for Craniotome No. 05.001.051

03.000.126 Burr, cranial, L, B 3.0 mm, head length 25 mm, for Craniotome No. 05.001.051

03.000.127 Burr, pin-shaped, S, B 1.4 mm, head length 6.0 mm

03.000.128 Burr, pin-shaped, M, B 1.4 mm, head length 6.0 mm

03.000.129 Burr, pin-shaped, L, B 1.4 mm, head length 6.0 mm

03.000.130 Burr, pin-shaped, S, B 2.1 mm, head length 12 mm

03.000.131 Burr, pin-shaped, M, B 2.1 mm, head length 12 mm

03.000.132 Burr, pin-shaped, L, B 2.1 mm, head length 12 mm

03.000.133 Burr, neuro, S, B 1.7 mm, head length 2.3 mm

03.000.134 Burr, neuro, M, B 1.7 mm, head length 2.3 mm



03.000.135 Burr, neuro, L, B 1.7 mm, head length 2.3 mm







03.000.142 Drill Bit, S, B 1.0 mm

03.000.143 Drill Bit, M, B 1.0 mm

03.000.144 Drill Bit, S, B 1.1 mm

03.000.145 Drill Bit, M, B 1.1 mm

03.000.146 Drill Bit, S, B 1.3 mm

03.000.147 Drill Bit, M, B 1.3 mm

03.000.148 Drill Bit, S, B 1.5 mm

03.000.149 Drill Bit, M, B 1.5 mm

03.000.150 Drill Bit, S, B 2.0 mm

03.000.151 Drill Bit, M, B 2.0 mm

03.000.152 Drill Bit, S, B 2.5 mm

03.000.153 Drill Bit, M, B 2.5 mm

03.000.154 Drill, wire-pass, S, B 1.1 mm, head length 5.0 mm

03.000.155 Drill, wire-pass, M, B 1.1 mm, head length 5.0 mm








03.000.170 Burr, round, length 28 mm, B 3.0 mm, with Mini Quick Coupling



03.000.173 Burr, egg-shaped, length 28 mm, B 7.0 mm, with Mini Quick Coupling




03.000.177 Burr, conical, length 23 mm, B 5.0 mm, with Mini Quick Coupling






03.000.183 Burr, pear-shaped, length 23 mm, B 5.0 mm, with Mini Quick Coupling






03.000.189 Burr, tapered fissure, length 31 mm, B 2.1 mm, with Mini Quick Coupling




03.000.193 Burr, circular, length 28 mm, B 8.0 mm, with Mini Quick Coupling




03.000.197 Lindemann Reamer, length 53 mm, B 2.3 mm, with Mini Quick Coupling

03.000.200 Burr, round, length 28 mm, B 3.0 mm, with J-Latch Coupling



03.000.203 Burr, egg-shaped, length 28 mm, B 7.0 mm, with J-Latch Coupling




03.000.207 Burr, conical, length 23 mm, B 5.0 mm, with J-Latch Coupling








03.000.213 Burr, pear-shaped, length 23 mm, B 5.0 mm, with J-Latch Coupling






03.000.219 Burr, tapered fissure, length 31 mm, B 2.1 mm, with J-Latch Coupling




03.000.223 Burr, circular, length 28 mm, B 8.0 mm, with J-Latch Coupling




03.000.227 Lindemann Reamer, length 53 mm, B 2.3 mm, with J-Latch Coupling

03.000.230 Burr, round, S, B 2.0 mm

03.000.231 Burr, round, M, B 2.0 mm

03.000.232 Burr, round, L, B 2.0 mm







03.000.239 Burr, barrel-shaped, S, B 4.0 mm, head length 9.0 mm

03.000.240 Burr, barrel-shaped, M, B 4.0 mm, head length 9.0 mm

03.000.241 Burr, barrel-shaped, L, B 4.0 mm, head length 9.0 mm

03.000.242 Burr, barrel-shaped, S, B 6.0 mm, head length 11 mm

03.000.243 Burr, barrel-shaped, M, B 6.0 mm, head length 11 mm

03.000.244 Burr, barrel-shaped, L, B 6.0 mm, head length 11 mm




03.000.248 Burr, pin-shaped, S, B 3.0 mm, head length 34.9 mm

03.000.249 Burr, pin-shaped, M, B 3.0 mm, head length 34.9 mm

03.000.250 Burr, pin-shaped, L, B 3.0 mm, head length 34.9 mm

03.000.300 Saw Blade 18 x 4.0 x 0.38 mm, for Sagittal Saw


03.000.301 Saw Blade 1526.020.38 mm, for Sagittal Saw



03.000.304 Saw Blade 1521020.38 mm, for Sagittal Saw







03.000.311 Saw Blade 26.5213.320.6 mm, crescent-shaped, for Oscillating Saw

03.000.312 Saw Blade 25216.320.6 mm, crescent-shaped, for Oscillating Saw

03.000.313 Saw Blade 30217.920.6 mm, crescent-shaped, for Oscillating Saw


03.000.320 Saw Blade 1326.4/2.920.6 mm, trapezoid, for Reciprocating Saw


03.000.322 Saw Blade 7.024.020.6 mm, for Reciprocating Saw

03.000.323 Saw Blade 1426.420.6 mm, for Reciprocating Saw


03.000.325 Saw Blade 2525.520.6 mm, for Reciprocating Saw, for Rhinoplasty

03.000.326S Saw Blade 2726.420.6 mm, for Reciprocating Saw



03.000.329 Saw Blade 34.525.0/2.520.6 mm, crescent-shaped, ascending, for Reciprocating Saw

03.000.330 Saw Blade 33.526.420.6 mm, with offset downwards, for Reciprocating Saw

03.000.331 Saw Blade 33.526.420.6 mm, with offset to the right, for Reciprocating Saw

03.000.332 Saw Blade 33.526.420.6 mm, with offset to the left, for Reciprocating Saw

03.000.334 Saw Blade 2026.4/2.920.6 mm, trapezoid, long, for Reciprocating Saw

03.000.335 Saw Blade 2726.4/2.920.6 mm, trapezoid, long, for Reciprocating Saw



03.000.338 Saw Blade 9.227.320.6 mm, for Inferior Border Osteotomy, left, for Reciprocating Saw

03.000.339 Saw Blade 9.227.320.6 mm, for Inferior Border Osteotomy, right, for Reciprocating Saw

03.000.340 Saw Blade, 105° angled, 7.021220.4 mm, shaft 70 mm, for Oscillating Saw






03.000.350 Trepan Burr B 7.0 mm

03.000.351 Trepan Burr B 12.0 mm

03.000.360 Rasp for Reciprocator 1125 mm, cross-grinding

03.000.361 Rasp for Reciprocator 1427 mm, cross-grinding

03.000.362 Rasp for Reciprocator 1125 mm, straight-grinding

03.000.363 Rasp for Reciprocator 1427 mm, straight-grinding

03.000.364 Broach for Reciprocator, small, proximal, 1924.524.5 mm

03.000.365 Broach for Reciprocator, small, distal, 162626 mm

03.000.370 Drill Bit B 1.0 mm with Stop, length 17.5/4 mm, 2-flute, for Mini Quick Coupling















03.000.390* Saw Blade, crescentic, radius 12 mm, 4520.6 mm







05.002.001 Saw Blade 116/9521920.89 mm, for Oscillating Saw















05.002.201 Saw Blade 111/90212.520.89 mm, for Oscillating Saw





05.002.301 Saw Blade 111/90219 –12.520.89 mm, for Oscillating Saw









511.411 Drill Bit B 2.0 mm with centering tip, length 148/122 mm, 3-flute, with Coupling for RLD










All cutting tools are also available sterile packed. Add suffix “S“ to article number. *Only available non-sterile packed.



03.010.100 Drill Bit B 3.2 mm calibrated, length 145/100 mm, 3-flute, with Coupling for RLD

03.010.101* Drill Bit B 4.2 mm calibrated, length 145/100 mm, 3-flute, with Coupling for RLD

03.010.102* Drill Bit B 5 mm calibrated, length 145/100 mm, 3-flute, with Coupling for RLD

511.905 Saw Blade for Reciprocating Saw 8021.05 mm




511.912 Saw Blade for Reciprocating Saw 6821.1 mm, toothed on both sides



511.915 Saw Blade for Reciprocating Saw for Top for Sternum

513.005 Drill Bit B 1.0 mm, length 46/34 mm, 2-flute, for Mini Quick Coupling












519.100 Saw Blade 70/4922720.6/0.4 mm, for Oscillating Saw with AO/ASIF Coupling




All cutting tools are also available sterile packed. Add suffix “S“ to article number. *Only available non-sterile packed.










519.118 Saw Blade 112/91212.520.9/0.8 mm, for Oscillating Saw with AO/ASIF Coupling






519.230 Saw Blade 46/2526.020.6/0.4 mm, for Oscillating Saw with AO/ASIF Coupling


532.041 Saw Blade 30/1526.020.4/0.3 mm

532.042 Saw Blade 30/1521020.4/0.3 mm

532.043 Saw Blade 30/1521620.4/0.3 mm

532.044 Saw Blade 33/1824.020.4/0.3 mm

532.045 Saw Blade 37/2228.020.4/0.3 mm

532.046 Saw Blade 37/2221220.4/0.3 mm

532.047 Saw Blade 46/3126.020.4/0.3 mm

532.048 Saw Blade 46/3121020.4/0.3 mm

532.061 Saw Blade 42/2726.020.6/0.4 mm

532.062 Saw Blade 42/2721020.6/0.4 mm

532.063 Saw Blade 42/2721420.6/0.4 mm

532.064 Saw Blade 65/5021020.6/0.4 mm

532.065 Saw Blade 65/5021420.6/0.4 mm

532.066 Saw Blade 65/5022020.6/0.4 mm

532.067 Saw Blade 65/5022720.6/0.4 mm

0123

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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