MAUDE Adverse Event Report: STRYKER GMBH IMN SCREWS - ADVANCED LOCKING SCREW D5X52.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23615052S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2025
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: "the fracture has varus and the distal advance locking screw has come out." the patient experienced pain.The revision surgery was performed on (b)(6) 2025.The nail was replaced.
Event or Problem Description
As reported: "the fracture has varus and the distal advance locking screw has come out." the patient experienced pain.The revision surgery was performed on (b)(6) 2025.The nail was replaced.
Additional Manufacturer Narrative
The reported event could be confirmed based on the provided x-rays pictures.The provided information and documentation were forwarded to medical affairs, with the following review: the nail is relatively short; the distal locking is quite close to the fracture.The revision nail is much longer.Second thing, it is noticeable that the primary nail is in the back of the femur distally not centrally in the fragment.The screws might not have had the appropriate hold in that area.These factors might have contributed to movement in the nail and screws and thus the loosening and secondary fracture dislocation.Based on the provided information, the root cause of the reported event is muti-factorial: the location of the fracture and the technical aspects of the surgical procedure may have contributed to the event.Furthermore, patient activity levels post-op, co-morbidities may also have contributed to an inadequate load distribution, and therefore the movement of the implant.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.Based on the investigation, the root cause was attributed to a combination of user and patient condition related issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: IMN SCREWS - ADVANCED LOCKING SCREW D5X52.5MM
• 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: 22885588
• Report Number: 0008031020-2025-01422
• Device Sequence Number: 4915662
• Product Code: HSB
• UDI-Device Identifier: 07613327381696
• UDI-Public: (01)07613327381696(17)350131(10)K0FA165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 23615052S
• Device Lot Number: K0FA165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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: 45 YR
• Patient Sex: Female