BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIOST-ELEV CURV-SHAFT ROUND EDG W/14 L

    MDR report key: 3180871 · Received June 20, 2013

    Report

    Report Number
    2520274-2013-03625
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    April 18, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTE
    PMA / PMN Number
    EXEMPT
    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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION HAS SHOWN THAT THIS IS A VERY OLD INSTRUMENT, MORE THAN 10 YEARS OLD. THE VISUAL INSPECTION REVEALED THE HANDLE IS MADE FROM CANEVASIT AND IS PARTIALLY WORN OUT AND THE SHAFT PRESENTS DISCOLORATIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND AND WE CONCLUDE THAT HIGH TEMPERATURE CYCLES DURING REPEATED STERILIZATION PROCESSES HAVE LED TO THIS OCCURRENCE. THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. (B)(6).

    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 NOT AVAILABLE AS DEVICE IS OLDER THAN 15 YEARS.

    Description of Event or Problem · 1

    THERE WAS THE START OF OXIDATION AT THE TRANSITION FROM THE STEEL PART TO THE HANDLE.THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279735 PERIOST-ELEV CURV-SHAFT ROUND EDG W/14 L HTE SYNTHES (USA) 2034

    Patients

    Seq Age Sex Outcome Treatment
    1