MAUDE Adverse Event Report: STRYKER GMBH IMN SCREWS - ADVANCED LOCKING SCREW D5X35MM; SCREW, FIXATION, BONE

Catalog Number	23615035S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the advanced screw became stuck with the nail, making removal difficult.Since it could not be removed, we inserted a second distal screw, removed the device, completed placement up to the end cap, then extracted the stacked lateral fixation screw and completed the procedure.".
Event or Problem Description
As reported: "the advanced screw became stuck with the nail, making removal difficult.Since it could not be removed, we inserted a second distal screw, removed the device, completed placement up to the end cap, then extracted the stacked lateral fixation screw and completed the procedure.".
Additional Manufacturer Narrative
Please note the correction to d9.The reported event could not be confirmed since the affected device was not returned.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.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.A review of the labeling did not indicate any abnormalities.More information as well as the device affected 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 D5X35MM
• 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 ; 2018315000
• MDR Report Key: 24235051
• Report Number: 0008031020-2026-00108
• Device Sequence Number: 10188564
• Product Code: HWC
• UDI-Device Identifier: 07613327381597
• UDI-Public: (01)07613327381597(17)330731(10)K164DB8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/29/2026

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: 23615035S
• Device Lot Number: K164DB8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 40 KG