MAUDE Adverse Event Report: Stryker GmbH GAMMA3 - LONG NAIL KIT R1.5, TI, LEFT D11X360MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2026
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, the surgery took place on (b)(6) 2025.It was further reported, the fracture of a long gamma3 nail in the area of the femoral neck screw, as well as fracture of a 5mm distal locking screw.No further information was provided.
Event or Problem Description
It was reported that, the surgery took place on (b)(6)2025.It was further reported, the fracture of a long gamma3 nail in the area of the femoral neck screw, as well as fracture of a 5mm distal locking screw.No further information was provided.
Additional Manufacturer Narrative
The reported event can be confirmed since the device was returned for evaluation and matches the alleged event.The returned nail was visually inspected and found to be broken into two fragments at the proximal web of the device.Minor deformation was also observed at the distal end of the fractured nail, consistent with prolonged loading from the lag screw during use.Microscopic evaluation of the broken surface indicated a mixed-mode failure mechanism involving both fatigue and brittle fracture.Distinct fatigue lines lines of rest were visible on the anterior aspect of the nail, identifying the site of crack initiation.Under repeated cyclic loading, the crack progressively propagated, reducing the structural integrity of the implant until complete separation occurred through the posterior web.The final fracture exhibited characteristics of brittle overload failure, evidenced by the smooth and shiny appearance of the fracture surface.Additionally, two k-wires were observed within the nail till the proximal lag screw insertion.Based on their location and condition, these k-wires were most likely used during the explantation procedure and are not considered contributory to the nail fracture.Therefore, they have been classified as concomitant findings.Of the two returned screws, one was found fractured through its midsection.The threads of both screws exhibited severe flattening and wear.The fracture surface of the broken screw showed extensive rubbing and surface damage, likely introduced during implant removal.Despite the post-retrieval damage, evaluation of the fracture characteristics suggested a failure mechanism involving both fatigue crack propagation and final brittle fracture.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.No product related issue could be detected during the performed investigation of the returned device.Regarding the root cause of the implant failure no conclusive statement can be provided, because key clinical information e.G.X-rays in different planes, clinical status, patient activity, assessment of the treating physician or operation reports is missing.The root causes in such cases are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and or the device in relation to cause of the failure.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, LEFT D11X360MM X 125DEG
• 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: 25667850
• Report Number: 0008031020-2026-00795
• Device Sequence Number: 12161777
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 35251360S
• Device Lot Number: K1DF665
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• 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: 06/02/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2024
• 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 Sex: Unknown