MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660100S
Medical Device Problem Codes	Positioning Failure (1158); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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: "during insertion of the lag screw, the lag screw was displaced anteriorly into the nail, and the lag screw was removed.The physician thought that the lag screw sleeve may have been pushed up by the fascia, so he added a new skin incision and redid the lag screw insertion technique, starting from the stage of reinserting the guide pin.The removed lag screw showed evidence of abrasion, so we replaced it with a new one.The new lag screw was inserted without any problem.The procedure was completed successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the investigation findings.The device inspection revealed the following: the lag screw shows ring marks on the shank, and the crest of threads is slightly worn out.It looks like that the lag screw had excess metallic contact during usage due to misalignment with the nail.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 user related issue.The event was by an incorrect alignment of the lag screw in the nail during usage.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during insertion of the lag screw, the lag screw was displaced anteriorly into the nail, and the lag screw was removed.The physician thought that the lag screw sleeve may have been pushed up by the fascia, so he added a new skin incision and redid the lag screw insertion technique, starting from the stage of reinserting the guide pin.The removed lag screw showed evidence of abrasion, so we replaced it with a new one.The new lag screw was inserted without any problem.The procedure was completed successfully.".

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X100MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 23003172
• Report Number: 0008031020-2025-01465
• Device Sequence Number: 21034215
• Product Code: HSB
• UDI-Device Identifier: 07613327591897
• UDI-Public: (01)07613327591897(11)250325(17)350228(10)K1178A6
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 81660100S
• Device Lot Number: K1178A6
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown