MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, LEFT GAMMA4 Ø12X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85252360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Necrosis (1971); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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: "at the time of the initial surgery, it was suspected a tumor at the fracture site and submitted the bone tissue for examination, which revealed necrosis of the tissue at the fracture site.After surgery, the patient worked hard on the rehabilitation, but he/she lost strength while squatting and the nail fracture was discovered.The nail removal and replacement with a bipolar is scheduled for (b)(6) 2025".
Additional Manufacturer Narrative
Correction - please refer to h6 clinical code.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.We received two x-ray images which confirm the reported course of nail breakage.The nail was found to be broken at the proximal end at the area of lag screw bore hole.As per event description a necrosis of the tissue at the fracture site was discovered and replacement by a bipolar is scheduled, which could be seen as a clear hint that sufficient bone healing is no longer expected and thus, patient related and classified as patient-patient factors issue.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.Adverse effects are clearly listed in the ifu and as pointed out ¿revision and additional surgery may be a consequence of these complications¿ with 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: "at the time of the initial surgery, it was suspected a tumor at the fracture site and submitted the bone tissue for examination, which revealed necrosis of the tissue at the fracture site.After surgery, the patient worked hard on the rehabilitation, but he/she lost strength while squatting and the nail fracture was discovered.The nail removal and replacement with a bipolar is scheduled for (b)(6) 2025.".

• Brand Name: LONG NAIL, LEFT GAMMA4 Ø12X360MM X 125°
• 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: 22029165
• Report Number: 0008031020-2025-00904
• Device Sequence Number: 12790324
• Product Code: HSB
• UDI-Device Identifier: 07613327475166
• UDI-Public: (01)07613327475166(17)330731(10)K1602AC
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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: 85252360S
• Device Lot Number: K1602AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2023
• 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 Sex: Unknown