BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LOCKING LONG

    MDR report key: 3181067 · Received June 20, 2013

    Report

    Report Number
    1719045-2013-01680
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 7, 2012
    Report Date
    June 13, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATES THE FOLLOWING: THE DEVICE WAS FORWARDED TO THE RESPONSIBLE DEVELOPMENT ENGINEER FOR EVALUATION AND THE REPORT STATES THE FOLLOWING: THE THREADED PART OF THE RETAINING SLEEVE IS INDEED BROKEN OFF. WE CAN ONLY SUPPOSE THAT THE PRIME LOCK THREAD HAD NOT BEEN FULLY THREADED INTO THE BONE SCREW, THIS, IN COMBINATION OF POSSIBLE MECHANICAL FORCE (SIDEWAYS) THROUGH SOFT TISSUE POSITIONING I PUSHING MAY HAVE LED TO THE DAMAGE OF THE TIP. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WHERE FOUND. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES, NO PRODUCT FAULT COULD BE DETECTED. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED: THE THREAD AT THE END OF THE SCREW DRIVER SHAFT HAS PEELED AWAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280092 RETAIN-SLEEVE LOCKING LONG LXH SYNTHES MONUMENT 6633547

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR