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

Catalog Number	81660100S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 event description that the procedure was completed without inserting the end cap, it is clearly an off label use since the operative technique is violated which clearly states that "fixation of the u-blade is always completed by securely fastening the u-blade end cap into the rc lag screw.Omitting the end cap or insufficient fixation may lead to loss of fixation and postoperative complications." if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the end cap fell off when opening the u-lag screw and became unclean.The screw was not replaced with another screw and the procedure was completed without inserting the end cap.".

• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22650189
• Report Number: 0008031020-2025-01310
• Device Sequence Number: 8823465
• Product Code: HSB
• UDI-Device Identifier: 07613327591897
• UDI-Public: (01)07613327591897(11)250217(17)350131(10)K10AF9E
• 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
• Report Date (Section B): 07/29/2025

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: 81660100S
• Device Lot Number: K10AF9E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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