MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, RIGHT D11X340MM X 130DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84301340S
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: surgeon contacted me on (b)(6) 2025 to book a gamma 4 removal set for next week as he is removing a broken nail.The nail was put in at fmc on (b)(6) 2025 by another surgeon.I will after the removal case on monday (b)(6) 2025 retrieve the broken implant and send it to the quality team in nsw." additional information received december 9, 2025: "revision was done yesterday (b)(6) 2025.It was completed successfully.Broken nail has been removed and competitor nail has been used to re-fix the fracture.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: surgeon contacted me on (b)(6) 2025 to book a gamma 4 removal set for next week as he is removing a broken nail.The nail was put in at (b)(6) on (b)(6) 2025 by another surgeon.I will after the removal case on monday (b)(6) 2025 retrieve the broken implant and send it to the quality team in (b)(6)." additional information received december 9, 2025: "revision was done yesterday (b)(6) 2025.It was completed successfully.Broken nail has been removed and competitor nail has been used to re-fix the fracture.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned nail is found broken.The device inspection revealed the following: the nail was received and found broken from its proximal web.Stress bearing points are clearly visible, indicating that excess compression forces were acting on the nail post-operatively.Proximal fragment of the broken nail shows signs of misdrilling, that is, the chamfer is damaged, and material slightly chipped from lateral anterior portion.This misdrilling most likely contributed to enable the crack initiation from lateral anterior region due to notching effect.Further, the lines of rest are clearly visible in the anterior portion of both proximal and distal fragments pointing towards a fatigue failure of the material due to repetitive cyclic loading and finally the catastrophic failure occurred as indicated by the uneven, rough portion in the posterior medial region when the implant was completely unable to withstand the applied load.Medical expert opinion on the provided information and x-ray: there seems to be some signs of bone healing, although it is also (very) limited in this long spiked subtroch fracture.One x-ray is not enough, but we can clearly see the lack of healing on the lateral side and the fracture line still extends medially.A second direction or a ct scan could definitely provide more clarity, but the fact of the matter is the nail broke, which is the most apparent proof the fracture did not heal.The bone did not consolidate, which you would have expected after this time.This delayed union going into non-union did contribute to the implant failure.As i usually point out during the medical trainings, fracture fixation is a balance of biology and mechanics.There is always a race between bone healing and construct failure; in this case the construct lost.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.No product related issue could be detected during the performed investigation of the returned device.The implant ultimately failed to withstand the applied force, resulting in material overload and fatigue failure.Based on the information provided, the root cause of the reported event is multi-factorial: the location of the fracture and the technical aspects of the surgical procedure contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - LONG NAIL, RIGHT D11X340MM X 130DEG
• 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 KIEL; 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: 23922213
• Report Number: 0008031020-2025-02311
• Device Sequence Number: 9013227
• Product Code: HSB
• UDI-Device Identifier: 07613327476293
• UDI-Public: (01)07613327476293(11)230221(17)330131(10)K10EFEC
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 84301340S
• Device Lot Number: K10EFEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 80 KG