BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICAWL Ø4 W/SILIC HAND L255 F/PEDIC SC

    MDR report key: 3161298 · Received June 11, 2013

    Report

    Report Number
    1719045-2013-01579
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    September 30, 2011
    Report Date
    October 20, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE TIP OF THE PEDICLE AWL IS INDEED COMPLETELY BROKEN OFF. WE DO SUPPOSE THAT FAR TOO MUCH MECHANICAL FORCE OR POSSIBLE INAPPROPRIATE HANDLING HAS CAUSED THE BREAKAGE OF THE TIP. PLEASE ENSURE TO FOLLOW THE RELEVANT OP INSTRUCTION IN ORDER TO ELIMINATE SUCH PROBLEMS IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF PEDICLE AWL BROKE OFF. THE TIP HAS BEEN DISPOSED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262871 PEDICAWL Ø4 W/SILIC HAND L255 F/PEDIC SC HWJ SYNTHES MONUMENT 566741F06

    Patients

    Seq Age Sex Outcome Treatment
    1