MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the hospital risk manager: "the patient reports having been operated on august 2023, in at another hospital, for a fracture of the proximal femur with a gamma 3 long nail.In december 2023, the patient went to another emergency room and found that the femoral fixation device had broken.They went to our hospital for the surgical removal and new osteosynthesis of the left femur.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
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.Based on investigation the nail breakage is not linked to a deficiency of the device but is rather considered patient related contributed by an intra-operative damage of the nail by a deviated lag screw step drill, which most likely had created the starting point of the fracture [notching effect].According to the damage and the evidence of the breakage surfaces, the nail broke in a fatigue fracture due to axial overload.Drill marks are found at the lateral entrance of the proximal thru hole for the lag screw at the anterior web; they progress through the bore towards medial.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 a male patient was initially treated with above implant due to a fracture of the proximal femur.According to further details provided the broken gamma3 long nail was revised by a synthes pfp plate which could be a hint to insufficient bone healing, which is supported by the hospital statement ¿¿the only risk factor for nonunion is that he is a smoker¿¿.Further details [like x-rays pre- / post op] were requested but to no avail and thus, a medical statement by a health care professional could not be given.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.4.5 months.Intra-operative implant damage and postoperative loads are listed as adverse effects in the ifu.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 by the hospital risk manager: "the patient reports having been operated on (b)(6) 2023, in at another hospital, for a fracture of the proximal femur with a gamma 3 long nail.In (b)(6) 2023, the patient went to another emergency room and found that the femoral fixation device had broken.They went to our hospital for the surgical removal and new osteosynthesis of the left femur.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM 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: 18473738
• Report Number: 0009610622-2024-00018
• Device Sequence Number: 6895506
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: 07613252273844
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 34251380S
• Device Lot Number: K025437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: 46 YR
• Patient Sex: Unknown