MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660090S
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
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: "during surgery with using gamma 4 u-lag screw, as it appeared that the femoral head were separated by hammering in the u-blade.".
Event or Problem Description
As reported: "during surgery with using gamma 4 u-lag screw, as it appeared that the femoral head were separated by hammering in the u-blade.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no evidence was provided for evaluation.The batch record could not be reviewed because the affected device was not returned, and the lot number communicated was incorrect.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information such as patient medical records as well as the affected device must be available in order to determine the exact root cause of the issue.The operative technique provides warnings for a safe procedure; take care during u-blade insertion with the hammer to avoid implant and/or bone damage.Observe the indicator rings of the rc guide and rc inserter to stop hammering when the u-blade is in its final position, indicator rings aligned.Take care during the procedure to avoid unintended bone and soft tissue damage which could lead to severe post-operative complications, such as avascular necrosis, which may lead to implant failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X90MM
• 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: 23357373
• Report Number: 0008031020-2025-01987
• Device Sequence Number: 8861023
• Product Code: HSB
• UDI-Device Identifier: 07613327591804
• UDI-Public: (01)07613327591804(17)350731(10)K13C14F
• 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,Followup
• Report Date (Section B): 12/21/2025

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: 81660090S
• Device Lot Number: K13C14F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2025
• 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 Age: 89 YR
• Patient Sex: Female