MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660085S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "while hammering the u-blade into place, it appeared the lag was driven too far, penetrating the bone head and reaching the acetabulum.The lag was repositioned to the indicated location, and the operation concluded.".

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X85MM
• 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: 24640122
• Report Number: 0008031020-2026-00426
• Device Sequence Number: 9797579
• Product Code: HSB
• UDI-Device Identifier: 07613327591798
• UDI-Public: 07613327591798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• 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
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 81660085S
• Device Lot Number: K180DE4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown