BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DIAMETER LOCKING SCREW

    MDR report key: 8139768 · Received December 6, 2018

    Report

    Report Number
    3011623994-2018-00050
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    September 13, 2018
    Report Date
    December 6, 2018
    Manufacturer
    TREACE MEDICAL CONCEPTS, INC.
    Product Code
    HWC
    UDI-DI
    00853114006006
    PMA / PMN Number
    K143717
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2.5 MM DIAMETER LOCKING SCREWS (1405-101X) ARE PROVIDED TO THE CUSTOMER WITHIN A STERILE KIT (SK12) AND MARKED SINGLE USE. THE UDI REFERENCED IS FOR THE STERILE KIT (SK12) THAT THE PRODUCT IS DISTRIBUTED WITHIN. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE HISTORY RECORDS FOR ALL SCREWS POSSIBLY IMPLANTED WERE REVIEWED (1405-1012 AND 1405-1014) AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURE AND RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED. IT WAS REPORTED THAT ONE (1) BACKED OUT SCREW WAS REMOVED ON (B)(6) 2018, DUE TO NOT BEING LOCKED IN PLACE. UPON REMOVAL, NO FAULT WAS FOUND WITH THE DEVICE. ALL REMAINING HARDWARE WAS LEFT IMPLANTED IN THE PATIENT. A NUMBER OF FACTORS COULD HAVE CONTRIBUTED TO THE BACKED OUT SCREW, HOWEVER BASED ON THE AVAILABLE INFORMATION THE MOST LIKELY CAUSE IS THE SCREW WAS NOT COMPLETELY LOCKED INTO THE PLATE WHICH RESULTED IN IT LOOSENING AND EVENTUALLY BACKING OUT. THE SURGICAL TECHNIQUE INCLUDES THE FOLLOWING STATEMENT REGARDING THE PROPER METHOD FOR INSERTING SCREWS INTO A PLATE: "ADVANCE THE SCREW INTO THE PLATE TO THE POINT WHERE LOCKING THREADS UNDER THE HEAD OF THE SCREW ENGAGE INTO THE RECEIVING THREADS IN THE PLATE. CONTINUE ADVANCING THE SCREW INTO THE BONE UNTIL A FIRM STOP IS ACHIEVED SIGNIFYING THE COMPLETE LOCK OF THE SCREW HEAD INTO THE PLATE. WHEN PROPERLY INSTALLED, THE HEAD OF THE SCREW SHOULD SIT FLUSH WITH THE TOP SURFACE OF THE PLATE." THE COMPANY WILL SUPPLEMENT THE MDR AS NECESSARY AND APPROPRIATE.

    Description of Event or Problem · 1

    AFTER AN ORIGINAL BUNION SURGERY WAS COMPLETED, ONE (1) BACKED OUT SCREW WAS REMOVED ON (B)(6) 2018, DUE TO NOT BEING LOCKED IN PLACE. UPON REMOVAL, NO FAULT WAS FOUND WITH THE DEVICE. ALL OTHER REMAINING TMC HARDWARE WAS LEFT IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979057 2.5MM DIAMETER LOCKING SCREW SCREW HWC TREACE MEDICAL CONCEPTS, INC. 1405-101X UNKNOWN 00853114006006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention