BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER

    MDR report key: 3041688 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10793
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 MANUFACTURING EVALUATION SHOWED NO VISIBLE SIGNS OF DAMAGE. THE INVESTIGATION OF THE COMPLAINED SCREWDRIVER SHOWS THAT THE PLASTIC HANDLE CHANGED THE SURFACE. THE SURFACE GOT CHEMICALLY ATTACKED DURING REPETITIVE WASHING AND STERILIZATION PROCEDURES. SINCE WE ARE NOT AWARE OF THE USED WASHING AND STERILIZATION PROCEDURES WE CONCLUDE THIS COMPLAINT TO BE INDETERMINATE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    SYNTHES (B)(4) REPORTED THAT THE HANDLES ON THE HEXAGONAL SCREWDRIVERS APPEAR TO HAVE STAINED THE STERI-PEEL POUCH (BOTH INSIDE AND OUTSIDE). THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THIS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143237 LARGE HEXAGONAL SCREWDRIVER HXX SYNTHES GMBH 2569877

    Patients

    Seq Age Sex Outcome Treatment
    1