MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LAG SCREW REAMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	14200240
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
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: "customer was not able to hit the nail correctly with the femoral neck screw drill.The nail was hit with the drill, this also happened with the second nail.The nail holding screws show signs of wear.".
Event or Problem Description
As reported: "customer was not able to hit the nail correctly with the femoral neck screw drill.The nail was hit with the drill, this also happened with the second nail.The nail holding screws show signs of wear." additional information: another nail was implanted after the first nail was removed.The result with the second nail was good; the drilled nail was not left in situ.
Additional Manufacturer Narrative
Please note the corrections to d1 and h6 health impact codes.The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned device could be confirmed based on the catalog number and lot number marked.There are no signs of damage or deformation on the lag screw reamer.Signs of misaligned drilling can be observed on the inner part of the lag screw hole of the nail, confirming the reported event.The returned nail, lag screw reamer and both nail holding screws were tested with fully functional targeting device, targeting sleeve and tissue protection sleeve samples.With both nail holding screws, the assembling could be performed as required and the reamer could be perfectly aligned with the lag screw hole.The observations from the functional inspection confirm that the devices are fully functional.Based on investigation, the root cause was attributed to an user related issue.The functional test enabled to rule out any device related issue.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 more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - LAG SCREW REAMER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23389611
• Report Number: 0008031020-2025-01991
• Device Sequence Number: 21343832
• Product Code: LXH
• UDI-Device Identifier: 07613327510133
• UDI-Public: 07613327510133
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 14200240
• Device Lot Number: KP513945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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