BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIOSTEAL ELEVATOR, ROUND, 6MM WIDE

    MDR report key: 3192978 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03579
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    April 23, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION HAS SHOWN THAT IT CONCERNS VERY OLD INSTRUMENTS, WHICH ARE MORE THAN 10 YEARS OLD. THE HANDLES MADE FROM (B)(4) ARE PARTIALLY WORN OUT AND THE SHAFTS PRESENT DISCOLORATIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND AND IT IS CONCLUDED THAT HIGH TEMPERATURE CYCLES DURING REPEATED STERILIZATION PROCESSES HAVE LED TO THIS OCCURRENCE. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    THERE WAS THE START OF OXIDATION AT THE TRANSITION FROM THE STEEL PART TO THE HANDLE. THIS IS 3 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293887 PERIOSTEAL ELEVATOR, ROUND, 6MM WIDE HTE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1