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 Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Malunion of Bone (4529); Implant Pain (4561)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "pathological lateral femoral neck fracture in the sense of an insufficiency fracture due to obesity in the absence of trauma, gamma nail surgery (b)(6) 2022 took place.In the course of tilting / varization of the femoral neck / femoral head and pseudarthrosis.Ct imaging of the nail fracture in the area of the femoral neck screw.Indication for material removal and cementless right hip tep.Surgery on (b)(6) 2024 was performed.".
Event or Problem Description
As reported: "pathological lateral femoral neck fracture in the sense of an insufficiency fracture due to obesity in the absence of trauma, gamma nail surgery (b)(6) 2022 took place.In the course of tilting / varization of the femoral neck / femoral head and pseudarthrosis.Ct imaging of the nail fracture in the area of the femoral neck screw.Indication for material removal and cementless right hip tep.Surgery on 02/08/2024 was performed.".
Additional Manufacturer Narrative
The reported event could be confirmed on a provided x-ray-copy.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Material documentation corresponded to the required values.A review of the labeling did not indicate any abnormalities.Potential risks of implant breakage are listed in the labelling.No indications of material, manufacturing or design related problems were found during the investigation.In case presented a 51-year-old male patient (bmi 41,55) had been treated with above nail on (b)(6) 2022, due to a pathological lateral femoral neck fracture in the sense of an insufficiency fracture due to obesity in the absence of trauma.In the course of this, tilting / varization of the femoral neck/femoral head and femoral neck/femoral head and pseudarthrosis.Ct imaging of the nail fracture in the area of the femoral neck screw.Indication for material removal and cementless right hip tep.Revision surgery was performed on (b)(6) 2024, after nearly 2 years of implantation.Permanent and repeated high load application will inevitably lead to implant breakage if the implant is not relieved by increasing bone healing.More detailed information about the complaint event as well as the affected device must be available.If more information is provided, the case will be reassessed.Based on investigation and based on given information, the root cause was attributed to a patient related issue.With available information a product deficiency was not verified.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18861716
• Report Number: 0009610622-2024-00093
• Device Sequence Number: 3325920
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: 04546540375124
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: K083037
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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 Age: 51 YR
• Patient Sex: Male