MAUDE Adverse Event Report: STRYKER GMBH ADVANCED LOCKING SCREW IMN SCREWS Ø5X37.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23615037S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "t2alphagt nail surgery.This was performed on a patient with a metatarsal and started with the insertion of a proximal screw.The proximal screw was inserted obliquely as planned, and while inserting the als into the proximal transverse static hole (distal on the proximal side), the screw became stuck and neither advanced nor returned.Surgeon tried to remove the als that had become stuck by combining a screwdriver bit long (b)(6) and a self-retaining screwdriver sleeve long (b)(6), but it was not possible".The (b)(6) no longer engaged with the (b)(6) properly.The als, which was protruding outward, was cut with an pin cutter, and the screw was safely cut.The procedure was completed with no problem.
Additional Manufacturer Narrative
Correction - please refer to b1, b2, d9 - the product was not returned, h1.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "t2alphagt nail surgery.This was performed on a patient with a metatarsal and started with the insertion of a proximal screw.The proximal screw was inserted obliquely as planned, and while inserting the als into the proximal transverse static hole (distal on the proximal side), the screw became stuck and neither advanced nor returned.Surgeon tried to remove the als that had become stuck by combining a screwdriver bit long (b)(6) and a self-retaining screwdriver sleeve long (b)(6), but it was not possible".The (b)(6) no longer engaged with the (b)(6) properly.The als, which was protruding outward, was cut with an pin cutter, and the screw was safely cut.The procedure was completed no problem.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X37.5MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21583335
• Report Number: 0008031020-2025-00397
• Device Sequence Number: 18359773
• Product Code: HSB
• UDI-Device Identifier: 07613327381702
• UDI-Public: (01)07613327381702(11)240411(17)340331(10)K1AD937
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: Health Professional
• Device Catalogue Number: 23615037S
• Device Lot Number: K1AD937
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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: Male