MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM X 130DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31301180S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "fracture of an implanted gamma nail, metal removal, the issue was noticed by the painful full weight bearing of the patient and by the xray images.Revision surgery was performed on (b)(6) 2025, the first surgery was performed on (b)(6) 2024, patient's activity level after implantation-fully loaded, painful.''.
Additional Manufacturer Narrative
Please note correction to h6 (device code and clinical code).The reported event could be confirmed since the device was returned for evaluation and provided radiograph alleged event good be confirmed.The received nail is completely broken in the webs of the proximal lag screw hole.Severe drill marks were found at the lateral entrance of the hole along one side of the proximal segment; they extend slightly inward through the bore toward the medial side.The drill marks were created by a deviated lag screw step drill, which most likely caused the initial fracture (notching effect) somewhere at the lateral edge.In addition to the drill marks, signs of excessive loading were noted.The lateral edge of the proximal part showed slight deformation caused by the lag screw step drill.The medial edge of the distal part also showed signs of deformation.This suggests the application of high compressive load.The fracture pattern resembles a fatigue fracture, as indicated by very slight lines of rest and a shiny fracture surface.Based on the radiograph, a medical opinion was sought: from the radiograph, the fracture is most probably subtrochanteric, not a normal trochanteric fracture.From a medical and biomechanical perspective this fracture is ideally treated with a long femoral nail.The short nail with only one distal screw does not provide the stability needed, 3 point fixation.The implant and the fracture will move, and thus the implant will break.We don't know when the breakage occurred, but the healing was compromised due to the movement in the fracture and thus there was movement in the lagscrew-nail function.There was most certainly a delayed union (revision 7 months post-op), and the lack of stability and continuous movement led to implant failure.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.Based on the provided information, the root cause of the reported event is multifactorial: 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 implants.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "fracture of an implanted gamma nail, metal removal, the issue was noticed by the painful full weight bearing of the patient and by the xray images.Revision surgery was performed on (b)(6) 2025, the first surgery was performed on (b)(6) 2024, patient's activity level after implantation-fully loaded, painful.''.

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22175431
• Report Number: 0008031020-2025-00954
• Device Sequence Number: 7788635
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: (01)04546540375124(17)271031(10)K0CC859
• 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): 08/26/2025

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: 31301180S
• Device Lot Number: K0CC859
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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