BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL FRAGMENT LCP INSTRUMENT & IMPLANT SET GRAPHIC CASE

    MDR report key: 2972538 · Received February 21, 2013

    Report

    Report Number
    3003787298-2013-10011
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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.

    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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE SMALL FRAGMENT LOCKING COMPRESSION PLATE (LCP) INSTRUMENT CASE WAS OPENED AND THE COATING ON THE DIVIDER HAD PEELED UP. THE CASE WAS RE-STERILIZED AND USED. IT WAS ALSO NOTED THAT RUST WAS DEVELOPING ALONG THE TRAY EDGES.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76853 SMALL FRAGMENT LCP INSTRUMENT & IMPLANT SET GRAPHIC CASE FSM SYNTHES JENNERSVILLE

    Patients

    Seq Age Sex Outcome Treatment
    1