BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK REMOVAL APPLIERS

    MDR report key: 3003650 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10158
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. DHR REVIEW PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL INSPECTION REVEALED THE MILLING GUIDE SHOWED NORMAL SIGNS OF WEAR AND TEAR BASED ON EXAMPLE SCRATCHES. THE CONCLUSION IS INDETERMINATE. HOWEVER, EXCESSIVE FORCE TO THE TIPS OF THE INSTRUMENT OR INCORRECT TECHNIQUE CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE EVALUATION DEPARTMENT THAT DURING A VEPTER SURGERY, THE LOCK REMOVAL PLIERS HAD BROKEN. TOOTH OF THE PLIERS BROKE OFF AND HIT THE ASSISTANT IN THE CHEEK. THE LOCK WAS REMOVED USING ANOTHER INSTRUMENT. THE BROKEN PIECE COULD NOT BE LOCATED. HOWEVER, IT WAS CONFIRMED NO BROKEN PIECES WERE LEFT IN THE PATIENT BY CM IMAGES AND X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88165 LOCK REMOVAL APPLIERS HTD SYNTHES GMBH T936193

    Patients

    Seq Age Sex Outcome Treatment
    1