MAUDE Adverse Event Report: STRYKER GMBH IMN INSTRUMENTS - ADJUSTING DEVICE FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533105
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during t2alphagt nail surgery, the sleeve could not be removed from the distal device, causing the procedure to be interrupted.The sleeve was finally removed by hammering it out.The device could be used normally afterward to completes the surgery.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d4 lot #.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.All devices were returned in a disassembled condition.The adjusting device and locking drill sleeve exhibit only normal usage marks without any significant damage.However, the tissue protection sleeve shows heavy scratch marks along the side periphery, suggesting contact with another metal component¿likely the drill sleeve during hammering.Additionally, the distal region is severely deformed, with the teeth bent inward, indicating that the sleeve was subjected to substantial force against another surface, mostly by hammer, causing the material to bend and resulting in significant deformation.A functional inspection of the device revealed a gap at the handles of both the tissue protection sleeve and the drill sleeve, indicating improper assembly likely caused by damage.Additionally, when attempting to pass the combination through all holes of the adjusting device, it was observed that due to the damaged teeth on the protection sleeve, it could not pass through one of the holes.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 device has been in use for the last 5 years, which eliminates any manufacturing problem.Damage around the return device indicates a usage error, pointing to a user-related root cause.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during (b)(6) nail surgery, the sleeve could not be removed from the distal device, causing the procedure to be interrupted.The sleeve was finally removed by hammering it out.The device could be used normally afterward to completes the surgery.".

• Brand Name: IMN INSTRUMENTS - ADJUSTING DEVICE 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 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: 23671845
• Report Number: 0008031020-2025-02106
• Device Sequence Number: 15879923
• Product Code: HSB
• UDI-Device Identifier: 07613327357035
• UDI-Public: 07613327357035
• 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,Followup
• Report Date (Section B): 01/21/2026

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: 23533105
• Device Lot Number: KME913388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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 Sex: Unknown