BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 3190031 · Received June 26, 2013

    Report

    Report Number
    1719045-2013-01714
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    December 2, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EVALUATION REVEALED THAT THE RIA DRIVE SHAFT WAS MANUFACTURED IN 2007. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THESE INSTRUMENTS. BASED ON THESE FINDINGS, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE CAN ONLY ASSUME THAT A SHORT TIME OVERLOADING CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SHAFT AND REAMER BROKE DURING THE PROCEDURE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290455 RIA DRIVESHAFT L520 HTO SYNTHES MONUMENT 14695-01

    Patients

    Seq Age Sex Outcome Treatment
    1