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

Catalog Number	81660090S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2025, orif using gamma 4 device was performed.Postoperatively, the patient was undergoing rehabilitation at another hospital.However, the patient complained of pain on the outer side of the lag screw.An x-ray taken on (b)(6) 2025 revealed that the end cap of the u-lag screw had become loose.Removal of the loose u-lag screw end cap was suggested, but the patient declined.As the x-ray in december showed it was still largely in place, the doctor decided continuing follow-up (monitoring) without removal surgery.The x-ray images were provided from the facility as they are requesting clinical review of them.".
Event or Problem Description
As reported: "on (b)(6) 2025, orif using gamma 4 device was performed.Postoperatively, the patient was undergoing rehabilitation at another hospital.However, the patient complained of pain on the outer side of the lag screw.An x-ray taken on (b)(6) 2025 revealed that the end cap of the u-lag screw had become loose.Removal of the loose u-lag screw end cap was suggested, but the patient declined.As the x-ray in december showed it was still largely in place, the doctor decided continuing follow-up (monitoring) without removal surgery.The x-ray images were provided from the facility as they are requesting clinical review of them.".
Additional Manufacturer Narrative
The reported event could be confirmed with the provided x ray images in which we can see gradual loosening of the end cap which confirms the event.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Since this is a mechanical failure, x rays only confirm the event but to evaluate the root cause of failure we need to make visual , functional and dimensional checks for which we need the reported product.If the device is returned or any further information is provided, the investigation report 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 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: 24457955
• Report Number: 0008031020-2026-00246
• Device Sequence Number: 21176201
• Product Code: HSB
• 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): 05/29/2026

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: 81660090S
• Device Lot Number: K10ACF1
• Was Device Available for Evaluation?: No
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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