MAUDE Adverse Event Report: Stryker GmbH IMN SCREWS - ADVANCED LOCKING SCREW D5X30MM; Screw, fixation, bone

Catalog Number	23615030S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "removal surgery was performed due to secondary fracture occurred in the femoral trochanteric region ipsilateral to the site of the implanted nail after bone union was achieved.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "removal surgery was performed due to secondary fracture occurred in the femoral trochanteric region ipsilateral to the site of the implanted nail after bone union was achieved.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.More information such as patient details & medical records must be available in order to determine the exact root cause of the issue.If the device is received or if any additional information is provided, the investigation will be reassessed.

• Brand Name: IMN SCREWS - ADVANCED LOCKING SCREW D5X30MM
• Common Device Name: Screw, fixation, bone
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker Trauma GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25882082
• Report Number: 0008031020-2026-00880
• Device Sequence Number: 20847384
• Product Code: HWC
• UDI-Device Identifier: 07613327381498
• UDI-Public: (01)07613327381498(11)210113(17)301231(10)K094DA2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23615030S
• Device Lot Number: K094DA2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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: Other
• Patient Sex: Unknown