MAUDE Adverse Event Report: Stryker GmbH IMN Instruments - Distal Targeting Arm Femur Antegrade; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533106
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during insertion of a distal locking screw using the gamma4 distal targeting device, drilling was performed with a locking drill.While advancing through the medial cortex, an audible sound was noted, and fluoroscopy confirmed that the drill had deviated posterior to the nail.The drill was withdrawn and drilling was reattempted.During the second attempt, a loud sound was heard and the drill stopped within the nail.Fluoroscopic evaluation confirmed that the drill remained within the intended trajectory, and drilling was continued.A subsequent loud sound was heard, and fluoroscopy revealed fracture of the drill approximately 25 mm from the tip while inside the nail.The fractured fragment was retrieved using forceps and a k-wire.The procedure was completed successfully without further complications.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: IMN Instruments - Distal Targeting Arm Femur Antegrade
• 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 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: 50348319
• Report Number: 0008031020-2026-01185
• Device Sequence Number: 20343406
• Product Code: HSB
• UDI-Device Identifier: 07613327357066
• UDI-Public: 07613327357066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172774
• 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
• Report Date (Section B): 08/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23533106
• Device Lot Number: KME921957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male