BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BENDING PLIERS - L165

    MDR report key: 3191469 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-02771
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    April 30, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. PART FRACTURED WHILE BENDING METAL PLATE AND WAS DUE TO UNDUE FORCE OR METAL FATIGUE. NO DEVICE NONCONFORMANCES WERE DETECTED. PRIOR ACTIVITY REGARDING THE HARDENING PROCESS OF THE PART, ADDRESSED IN PREVIOUS CORRECTIVE ACTION ARE CITED IN THE EVALUATION AND A CAPA DETERMINATION HAS BEEN INITIATED FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLIERS BROKE WHILE BEING USED AS INTENDED TO BEND A PLATE. IT WAS REPORTED THAT ALL FRAGMENTS FROM THE BREAKAGE WERE RETRIEVED WITHOUT INCIDENT AND THEIR WAS NO INCREASE IN THE TIME OF SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291466 UNIVERSAL BENDING PLIERS - L165 UNIVERSAL BENDING PLIERS HTC SYNTHES GMBH A7RA23

    Patients

    Seq Age Sex Outcome Treatment
    1