BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3160586 · Received June 10, 2013

    Report

    Report Number
    1719045-2013-01572
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    June 1, 2012
    Report Date
    June 4, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE VISUAL INVESTIGATION SURROUNDING THE FAULTY RETAINING SLEEVE HAS SHOWN THAT THE THREAD IN THE FORE PART WAS TORN. UNFORTUNATELY IT IS NOT POSSIBLE FOR US TO RETROSPECTIVELY RECONSTRUCT THE DAMAGE (AS THERE HAS BEEN NOT DETAILED INFORMATION GIVEN TO US). WE CAN SIMPLY ASSUME THAT THE DAMAGE WAS CAUSED BY SIGNIFICANT MECHANICAL USAGE. NO DISCREPANCY WAS FOUND IN THE MATERIAL AND PRODUCTION DOCUMENTS, PRODUCT FAULT COULD BE FOUND. THE INVESTIGATION DETERMINED THE COMPLAINT TO BE INDETERMINATE.

    Description of Event or Problem · 1

    THE THREADED TIP IS DAMAGED, CRACKED. THE RETAINING SLEEVE TORE WHILE SCREWING IN THE BONE SCREW. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260019 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6698485

    Patients

    Seq Age Sex Outcome Treatment
    1