MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251200S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the patient has a gamma nail with a u-blade and this should be replaced.The nail is broken in the area where the femoral neck screw passes through.The nail was removed and a new one was implanted.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the patient has a gamma nail with a u-blade and this should be replaced.The nail is broken in the area where the femoral neck screw passes through.The nail was removed and a new one was implanted.".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned nail was confirmed based on the catalog # and the lot # marked.The implant is broken in two parts, at the level of the lag screw hole.Both parts were returned.The evaluation revealed that the nail broke due to fatigue after 6 months of implantation.This can be stated based on the lines of rest clearly visible on the posterior side of the nail, which are a classic indication of a fatigue fracture.According to the observations made, the fatigue fracture had its origination in the lateral side of the posterior portion of the lag screw hole.Material damage, which was caused by misaligned drilling, may have weakened the device and contributed to the breakage.This statement is confirmed by the significant signs of wear (shiny area) on the posterior side of the hole.The anterior side of the lag screw hole shows evidence of a secondary fatigue fracture and a of sudden "catastrophic" brittle fracture, resulting from both fatigue fractures.Material deformation (bearing points) be observed on the edge of the proximal hole, below the lag screw.This indicates that the nail was subjected to severe loads, leading to displacement of the lag screw, associated with the breakage of the nail.This statement is confirmed by the wear marks observed on the returned lag screw.X-ray images were received for inspection: two following the operation and two after 6 months.In the two first pictures, an extensive pertrochanteric fracture can be observed.Due to the low quality of the images, no statement regarding fracture reduction could be done.The two next pictures did not give any useful information, as nothing could be stated due to their low quality.The exact root cause of the nail's failure could not be determined.Additional information would be needed to conduct a more thorough investigation, such as patient's medical records and details of their postoperative behavior.Furthermore, higher-resolution x-rays would have been necessary.The misdrilling most probably contributed to the fracture, by facilitating and/or accelerating its development.However, it is unlikely to have been the main cause.Any manufacturing related issue could be ruled out.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.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM 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 KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22235917
• Report Number: 0008031020-2025-00967
• Device Sequence Number: 15713894
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: (01)04546540375087(17)290831(10)K1D7748
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 31251200S
• Device Lot Number: K1D7748
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 94 KG