MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31301180S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "failed short gamma nail.The surgeon identified concern at 8 week post operation.Nail is broken at the proximal end of the nail / lag screw junction.Issue noticed: post operative 8 weeks.Retrospectively upon further investigation by consultant".
Additional Manufacturer Narrative
The reported event could be confirmed based on details provided, only.Images available revealed a broken nail.Due to missing device a physical evaluation was impossible.In the case presented, a 77-year-old female patient at the time of the reported event, was initially treated on (b)(6) 2024 with the trochanteric nail set shown above, ti gamma3 ø11x180mm x 130, which was noticed to be broken during postoperative imaging 8 weeks.The affected nail is designed to withstand the normal loads during the implantation period, i.E., the implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.No dated image was made available for time point 8 weeks post operation but one dated image (b)(6) 2025 which confirms the course of broken nail at proximal bore hole.However, the provided details and x-ray images available for the current case were forwarded to a medical expert for review and statement ¿ his comments [excerpts]: this is a subtrochanteric fracture.From a medical and biomechanical perspective this fracture should not have been treated with a short nail since the one distal screw does not provide the stability needed.The implant and the fracture will move and thus the implant will break.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.Whether or not a pre-damage of the nail occurred during the procedure was unable to be verified due to missing item.Since a physical evaluation was impossible, further technical statement could not be made and an exact root cause could not be given.Adverse effects are clearly listed in the ifu and as pointed out, revision and additional surgery may be a consequence of these complications.With the information available no deficiency of the nail 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 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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "failed short gamma nail.The surgeon identified concern at 8 week post operation.Nail is broken at the proximal end of the nail / lag screw junction.Issue noticed: post operative 8 weeks.Retrospectively upon further investigation by consultant".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X180MM X 130°
• 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: 22078119
• Report Number: 0008031020-2025-00911
• Device Sequence Number: 9363131
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: (01)04546540375124(17)290430(10)K1B2B44
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: K1B2B44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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: 77 YR
• Patient Sex: Female