MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported by australian registrar that there had a broken femoral nail.Additional information received 1/2/24: issue noticed after follow up x-rays fracture clinic.Patient required removal of broken hardware and revision to total hip replacement.Right side.Reason for revision: fracture non-union + implant breakage.".
Event or Problem Description
It was reported by australian registrar that there had a broken femoral nail.Additional information received 1/2/24: issue noticed after follow up x-rays fracture clinic.Patient required removal of broken hardware and revision to total hip replacement.Right side.Reason for revision: fracture non-union + implant breakage.".
Additional Manufacturer Narrative
The reported event could be confirmed since physical inspection matches the reported failure mode; received nail was completely broken in the webs of the proximal drill hole for the lag screw.According to the damage and the evidence of the breakage surfaces, the nail broke in a fatigue fracture due to axial overload.Bearing points are typical results of the interaction of the single products under load.Areas with signs of friction / seizing [bearing points of lag screw] are visible at the lateral edge of the proximal part.Similar areas were identified at the distal medial edge.The counterparts were found on the lag screw in the areas with corresponding friction signs and worn edges.The appearance identified a high axial load application to the implants.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.In the case presented an 86-year-old patient, gender unknown, was initially treated with above implant which was revised to a total hip replacement.This could be seen as a hint that sufficient bone healing is no longer be expected, which is confirmed by further details provided ¿¿reason for revision: fracture non-union + implant breakage ¿ revised to total hip replacement.¿.Furthermore, a sequence of x-ray images received was forwarded to a medical expert for statement and following was stated [excerpts]: ¿¿depending on the timelines (initial surgery vs breakage, vs revision) it is likely a non-union occurred.This is what would have happened in most patients irrespective of any patient factors¿¿.Finally, as pointed out in the ifu ¿the risk of post-operative complication [e.G.Failure of an implant] is higher if patients are obese¿¿ and based on data provided an increased bmi was also be verified.Axial overload had led to continuous stresses and a significant weakening of the nail in the area of the lag screw thru hole, followed by the fatigue fracture after an implantation duration of approx.9.5 months.Based on the above the nail breakage was not linked to a deficiency of the device but was rather patient related.Adverse effects [e.G.Non-union] are clearly listed in the ifu and as pointed out ¿¿revision and additional surgery may be a consequence of these complications¿¿.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.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18713166
• Report Number: 0009610622-2024-00070
• Device Sequence Number: 15267798
• Product Code: HSB
• UDI-Device Identifier: 07613252273837
• UDI-Public: 07613252273837
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 34251360S
• Device Lot Number: K0E0E38
• 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: 01/21/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2021
• 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: Prefer Not To Disclose
• Patient Weight: 99 KG