BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3193266 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03979
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    July 20, 2012
    Report Date
    August 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(6). DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THERE IS A SLIGHT DEFORMATION CLOSE TO THE MIDDLE OF THE LOWER NOSE VISIBLE. BECAUSE OF THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. BASED ON THE PROVIDED DETAILS AND THE APPEARANCE OF THE PLIERS THE EXACT CAUSE CANNOT BE DEFINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FIRST TIME OF USE AFTER PURCHASING THE INSTRUMENT, WHEN BENDING A PLATE WITH THE CONCERNED INSTRUMENT DURING THE OPERATION, THE TIP OF THE BENDER WAS DAMAGED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292576 BEND/CUT-PLIERS W/NOSE F/LOCK-PL 2 HXP SYNTHES GMBH 7695620

    Patients

    Seq Age Sex Outcome Treatment
    1