MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LAG SCREW D10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600095S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the implant failed.The doctor described it as the lag screw caused the nail itself to bend causing the nail to break into two.It broke where the lag screw sits in the nail itself.The patient underwent a revision surgery.
Event or Problem Description
It was reported that the implant failed.The doctor described it as the lag screw caused the nail itself to bend causing the nail to break into two.It broke where the lag screw sits in the nail itself.The patient underwent a revision surgery.
Additional Manufacturer Narrative
Correction - please refer to d9 - product not returned.The reported event of adverse impact to patients - postoperatively could be confirmed since there was a reported revision due to the breakage of the counterpart nail.General aspects: the counterpart nail used is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation.During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product.Usually, a breakage is contributed to one or more deficits, e.G.Insufficient bone healing, product damage.Generally, the risk of breakage will increase with the increase of load cycles and load level.Nail breakage in general has been experienced but does not present an unanticipated event.Depending on load application, also, depending on the patient¿s post implant behavior and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities ¿ a nail breakage can rather be classified as anticipated; specifically, if one or more contributing issues concurrence with each other.In the case presented an 80-year-old female patient was initially treated with above shown implant and a counterpart gamma4 - intermediate nail, right d11x240mm x 125deg on (b)(6) 2025, which was noticed to be broken on (b)(6) 2026 and also with reported other relevant history of: osteoporosis, si joint arthritis, hyperlipidemia, restless legs syndrome, depression, anxiety.According to event details given within product inquiry.Patient underwent 5 hour revision surgery.Which could be a hint to insufficient bone healing after an implantation period of appr.9 months.Further details e.G.Medical records, x-rays etc.Were repeatedly requested but to no avail.One requirement for successful nail treatment is a timely bone healing to relieve the nail over the progressing time of implantation.Potential adverse effects are clearly pointed out in the labelling.In most instances implant breakage is rather clinical than device related.Adverse effects and events are clearly pointed out in the corresponding labelling.However, since the lag screw was not made available neither a physical evaluation was possible nor a further technical statement could be made for the lag screw in question.With given details no discrepancy for the lag screw in question could be verified.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.In case substantive information becomes available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: GAMMA4 - LAG SCREW D10.5X95MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24333522
• Report Number: 0008031020-2026-00172
• Device Sequence Number: 4914316
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 81600095S
• Device Lot Number: K1E08DA
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 146 LB
• Patient Race: White