BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECOMET

    MDR report key: 11552963 · Received March 23, 2021

    Report

    Report Number
    11552963
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 12, 2021
    Report Date
    March 16, 2021
    Manufacturer
    TECOMET INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE TIP OF A TECOMET REUSABLE SURGICAL SCREWDRIVER BROKE INTO SEVERAL PIECES DURING THE REMOVAL OF ORTHOPEDIC SPINAL HARDWARE. SEVERAL PIECES WERE SEQUESTERED. HEALTH CARE PROVIDERS BELIEVE THAT THESE SCREWDRIVER TIPS BECOME WORN DOWN OR WEAKENED WITH MULTIPLE USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455401 TECOMET BIT, DRILL HTW TECOMET INC. HD207T10

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA