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

Catalog Number	81600100S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, during a post-operative check-up, medialization of the shs was detected.The revision surgery was performed with g4 u-blade.No further information was provided.
Event or Problem Description
It was reported that, during a post-operative check-up, medialization of the shs was detected.The revision surgery was performed with g4 u-blade.No further information was provided.
Additional Manufacturer Narrative
Correction: lot number corrected (from k1150c2 to k115dc2).The reported event could be confirmed, since the reported medial migration of the lag screw could be confirmed on the received x-ray.The device inspection revealed the following.The lag screw was returned for evaluation.The visual inspection has shown that there are different damages at the shaft of the lag screw visible.The anodized layer is not present anymore at the damages, which indicates that they were caused post-manufacturing, either during insertion, insitu or extraction.The laser markings are not fully readable as there are stress marks present, the catalog- and lot number could be verified with the manufacturing documents.A microscopic inspection of the lag screw was performed.There are clearly visible weight bearing marks on the top (red circle) and as well at the bottom side of the lag screw visible.The marks indicate that the lag screw did stay for a longer period in the correct position, while it was exposed to weight bearing.There are also marks of the set screw visible at the side walls of the groove.But there is no impression mark visible at the bottom of the groove.This indicates that the set screw was placed in the groove as intended, but possible not deep enough since there is no mark at the bottom visible.At the end of the groove are clearly visible impression marks from the set screw visible, this shows that the lag screw did migrate to this point where it finally was stopped by the screw.Such a migration within the groove is only possible if the screw is not inserted deep enough.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 labelling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was most likely attributed to a user related issue.The observed marks at the lag screw indicate that the set screw was either not deep enough inserted or the set screw was more than more than a quarter of a turn unscrewed after the insertion.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - 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 GMBH; 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: 24277868
• Report Number: 0008031020-2026-00126
• Device Sequence Number: 9926748
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K213328
• 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): 06/04/2026

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: 81600100S
• Device Lot Number: K115DC2
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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