BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCL-CABLE W/CRIMP Ø1.7 SST

    MDR report key: 3183574 · Received June 22, 2013

    Report

    Report Number
    1719045-2013-01621
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    July 21, 2011
    Report Date
    August 24, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE CABLES ARE DAMAGED WITH FILAMENTS BROKEN. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THESE CABLES WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED THE INSPECTIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. NEVERTHELESS, A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLES ARE DAMAGE, FILAMENTS BROKEN. THE FILAMENTS BROKE BEFORE STARTING TO TIGHTEN THE CABLES. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284085 CERCL-CABLE W/CRIMP Ø1.7 SST JDQ SYNTHES MONUMENT P904424

    Patients

    Seq Age Sex Outcome Treatment
    1