MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 Ø3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18063540
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "breakage of 3.5 mm drill.Breakage occurred when the affected leg was rotated internally and externally to confirm the direction of the distal transverse stop drill.".
Additional Manufacturer Narrative
Please note the correction to h6 health impact code.The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The returned drill was visually inspected, in we can see that the drill is broken from the distal end, and the broken fragment was not returned for inspection.After a microscopic view, we can see nick marks on the cutting flutes caused by the usage of the device over time.The fracture surface indicates a brittle fracture, smooth and shining in nature, caused by the application of high tensile and torsional forces, also with wear and tear over the years.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation root cause can be attributed primarily to user related as breakage is caused by application of excessive torsional force, but wear and tear on the device can be also a contributor as device is manufactured in 2015 with around 10 years of usage.If further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "breakage of 3.5 mm drill breakage occurred when the affected leg was rotated internally and externally to confirm the direction of the distal transverse stop drill.".

• Brand Name: DRILL, AO T2 Ø3,5X230 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22166438
• Report Number: 0008031020-2025-00953
• Device Sequence Number: 15400951
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: (01)04546540196606(11)150925(10)K0ADEE0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 18063540
• Device Lot Number: KU57249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown