MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965050S
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." (b)(6) 2025 - during full product inspection, it turned out that a tiny part of locking screw tip is broken.
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." (b)(6) 2025 - during full product inspection, it turned out that a tiny part of locking screw tip is broken.
Additional Manufacturer Narrative
The reported event could be confirmed since physical inspection matches the reported failure mode; locking screw was found with a broken tip and the along received nail was completely broken in the webs of the proximal drill hole for the lag screw.The received locking screw was found with a broken tip.The broken off part was not returned.Threaded windings at tip were found to be significantly flattened and breakage surface presents a smooth topography.According to the damage and the evidence of the breakage surface, the item broke in a fatigue fracture due to overload.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 screw is not designed to take over the intended use of nail in case of a non-intact situation occurs.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 such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.Due to the broken nail, there was increased force transmission to the locking screw, which then finally broke as a result of overload.Axial overload had led to continuous stresses and a significant weakening of the implant(s) (for the nail in the area of the lag screw thru hole, followed by the fatigue fracture).Based on the above, the breakage was not linked to a deficiency of the device(s) 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.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X50 MM
• 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: 22796509
• Report Number: 0008031020-2025-01362
• Device Sequence Number: 8643226
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: (01)04546540202512(17)281231(10)K19CD19
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032244
• 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): 09/11/2025

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: 18965050S
• Device Lot Number: K19CD19
• 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): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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