MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW STEP DRILL GAMMA3 Ø10.5X495 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200191
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the surgeon reports a problem with a gamma nail.The lag screw step drill is twisted.".
Additional Manufacturer Narrative
Corrections: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon reports a problem with a gamma nail.The lag screw step drill is twisted.".
Event or Problem Description
As reported: "the surgeon reports a problem with a gamma nail.The lag screw step drill is twisted.".
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned and h6 (method, results and conclusion codes).The reported event could be confirmed based on the device inspection.The device inspection revealed the following: the drill exhibits considerable wear, as evidenced by blunt and deformed flutes that indicate extensive use.The need for increased force when operating with dull flutes suggests prolonged and intensive use, likely resulting in tip deformation over time.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 investigation, the root cause was attributed to a combination of wear and user-related factors.The event resulted from extensive usage overtime and the application of excessive external force that ultimately led to the flutes deformation.Additionally, the device was manufactured in 2016 and has been in service for a long period which is most likely a contributing factor.In this relation, the stryker instructions for cleaning, sterilization, inspection and maintenance provide information to identify when the device should no longer be reused or is still within specification.When cleaned, sterilized and maintained according to the instructions provided within this document and documents referenced therein, the reusable medical devices maintain their function and biocompatibility over the lifetime of the device.If more information is provided, the case will be reassessed.

• Brand Name: LAG SCREW STEP DRILL GAMMA3 Ø10.5X495 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA GMBH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22004298
• Report Number: 0008031020-2025-00885
• Device Sequence Number: 21179754
• Product Code: LXH
• UDI-Device Identifier: 04546540713421
• UDI-Public: (01)04546540713421(11)160823(10)K0BFA0C
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 13200191
• Device Lot Number: KU62381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 03/04/2026
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/22/2025; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2016
• 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