MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251400S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the patient was implanted with the long gamma3 nail described above on (b)(6) 2024 for a subtrochanteric fracture on the left.He was able to be mobilized under full weight-bearing during the procedure.A fracture of the long gamma nail was diagnosed during a follow-up x-ray examination, which was performed due to pain.On (b)(6) 2025, revision surgery was performed with explantation of the broken gamma 3 nail on the left.".
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 which is also supported by signs of damage verified at one locking screw.In the case presented a 67-year-old male patient was initially treated on (b)(6)2024 with above implant which was revised appr.10 months later (b)(6)2025 since nail was found to be broken during a follow-up x-ray examination, which was performed due to pain.Furthermore, it was stated per event description.He was able to be mobilized under full weight-bearing during the procedure, as neither medical records nor x-ray images of the pre and postoperative situation in different views [m-l and a-p view] were made available, a medical statement regarding initial treatment situation or the current healing status after an implant duration of appr.10 months was impossible.Nail breakage in general has been experienced but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities ¿ a nail breakage can rather be classified as anticipated; specifically, if one or more contributing issues concurrence with each other.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.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.Based on the above the nail breakage was not linked to a deficiency of the device but was rather patient related.Adverse effects 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.
Event or Problem Description
As reported: "the patient was implanted with the long gamma3 nail described above on (b)(6)2024 for a subtrochanteric fracture on the left.He was able to be mobilized under full weight-bearing during the procedure.A fracture of the long gamma nail was diagnosed during a follow-up x-ray examination, which was performed due to pain.On (b)(6)2025, revision surgery was performed with explantation of the broken gamma 3 nail on the left.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X400MM 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22072283
• Report Number: 0008031020-2025-00910
• Device Sequence Number: 15631160
• Product Code: HSB
• UDI-Device Identifier: 07613252274315
• UDI-Public: (01)07613252274315(11)201014(17)250930(10)K0CA703
• 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: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 35251400S
• Device Lot Number: K0CA703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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: 67 YR
• Patient Sex: Male