MAUDE Adverse Event Report: Stryker GmbH Gamma4 - Lag Screw D10.5x105mm; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600105S
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
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
The following information was reported: medial migrating lag screw of the gamma4.
Event or Problem Description
The following information was reported: medial migrating lag screw of the gamma4.
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event can be confirmed since the device was returned for evaluation, and the available information matches the alleged event.The returned nail, lag screw, and locking screw were received for evaluation.The locking screw was considered a concomitant component as no direct correlation to the reported event could be established.Visual inspection of the nail revealed damage around the proximal lag screw aperture, which is consistent with drill contact during implantation.Additionally, damage was observed on the set screw threads and screw head, suggesting the application of significant force during surgical handling.Examination of the lag screw identified markings along the groove walls, indicating that the set screw was not fully aligned with the center of the groove and was engaged eccentrically.Sliding marks were also observed within the groove, which correlate with the damage noted on the teeth of the set screw.Furthermore, evidence of set screw movement in the medial direction was observed based on wear and damage present at three distinct locations along the groove walls.With available radiograph a formal medical opinion was sought: generic probable causes of migration is that the set screw was not engaged in the groove at all, or too loose.The latter can be caused by too much movement in the junction of the lags crew and the nail due to instability.Instability is usually related to fracture patterns and/ or the poor reductions.The reduction does not seem to be ideal, there is quite a fracture gap on the lateral view and there is a strange shadow on the ap medial of the nail, which should not be there.This implies the reduction was not ideal.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 above analysis, the root cause of the reported event is user-related.Evaluation of the returned components identified markings on the lag screw groove walls, indicating that the set screw was eccentrically positioned and not properly aligned within the center of the groove and further contributing factors are fracture patterns and poor reductions.If any additional information is provided, the investigation will be reassessed.

• Brand Name: Gamma4 - Lag Screw D10.5x105mm
• 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 GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25780771
• Report Number: 0008031020-2026-00831
• Device Sequence Number: 9625861
• Product Code: HSB
• UDI-Device Identifier: 07613327511048
• UDI-Public: (01)07613327511048(17)351031(10)K17F32F
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: Lay User/Patient
• Device Catalogue Number: 81600105S
• Device Lot Number: K17F32F
• Date Returned to Manufacturer: 06/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• 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