MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660080S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the u-blade was difficult to insert, and while attempting to drive it in with a hammer, the lag screw perforated the femoral head and advanced into the acetabulum." the nail and lag screw were replaced to complete the procedure.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned and h6 (method and results codes).The reported event could be confirmed since the device was returned for evaluation matches the alleged event.Visual inspection of the returned devices revealed multiple indications of mechanical interaction and deformation.Distinct rub marks were observed on the nail in the region surrounding the lag screw, suggesting that the lag screw contacted and rubbed against the nail during use.The pre-inserted cannulated lag screw was found outside its designated groove and showed significant deformation.The tip of the screw was bent inward, with shiny, polished areas consistent with frictional wear.This appearance indicates material deformation and rubbing under load.Additional damage was noted at the groove areas corresponding to the u-blade and set screw interfaces.The deformation pattern at these locations is consistent with the application of high locking forces, and the presence of damage on both grooves suggests rotational movement of the lag screw.Rub marks were also present on the u-blade, indicating that it was inserted; however, a high impact force appears to have been applied, causing the u-blade to rub extensively against the grooves of the lag screw.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.The operative technique states that: ¿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).¿ [original statements].No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation, the deformation observed on the returned components indicates exposure to high-impact forces; however, without clinical information such as intraoperative radiographs, the exact root cause cannot be determined.A probable explanation for the screw movement and associated damage is the application of excessive impact force during the u-blade even after insertion from hammering.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the u-blade was difficult to insert, and while attempting to drive it in with a hammer, the lag screw perforated the femoral head and advanced into the acetabulum." the nail and lag screw were replaced to complete the procedure.

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X80MM
• 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: 23868632
• Report Number: 0008031020-2025-02205
• Device Sequence Number: 11871618
• Product Code: HSB
• UDI-Device Identifier: 07613327591729
• UDI-Public: (01)07613327591729(17)341231(10)K0FDA6A
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 81660080S
• Device Lot Number: K0FDA6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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: Required Intervention
• Patient Sex: Unknown