BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM

    MDR report key: 3191227 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03809
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A TENDON REATTACHMENT SURGERY ON (B)(6) 2013, THE HEAD OF A 4.0 MM CANCELLOUS SCREW BROKE APART AND POPPED OFF DURING THE FINAL TIGHTENING. THE SHAFT FRAGMENT WAS LEFT IN THE BONE AND THE HEAD OF THE SCREW WAS RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289950 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR