BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM THREADED GUIDE WIRE 230MM

    MDR report key: 2945607 · Received February 6, 2013

    Report

    Report Number
    2520274-2013-00736
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    DQX
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SURGERY IN (B)(6) 2013 A FEW OF THE THREADED GUIDE WIRES HAD A BLACK COATING THAT PEELED OFF THE WIRES. THE GUIDE WIRES WERE ASSEMBLED AND LOADED ON THE DRILL TRUCK AND THEN MECHANICALLY SPUN. THE MECHANICAL SPINNING CAUSED THE COATING TO RIP OFF OF THE GUIDE WIRES. THE SURGEON CONTINUED THE SURGERY AND ONLY USED THE WIRES WHERE THE COATING REMAINED INTACT. THIS IS 3 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49844 2.0MM THREADED GUIDE WIRE 230MM GUIDE WIRE DQX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRES