BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEND/CUT-PLIERS W/NOSE F/LOCK-PL 2

    MDR report key: 3173841 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03334
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 PLIERS HAVE THE NOSE BROKEN. AS THE BROKEN NOSE WAS NOT SENT BACK FOR INVESTIGATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. WE ARE NOT AWARE OF ANY SIMILAR OCCURRENCE REGARDING TO THIS LOT. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRONG BROKE OFF THE BENDING INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272873 BEND/CUT-PLIERS W/NOSE F/LOCK-PL 2 HXP SYNTHES GMBH 3660041

    Patients

    Seq Age Sex Outcome Treatment
    1