BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-SHAFT Ø9 L360 W/FIXED REAMER HEAD

    MDR report key: 2943038 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-00787
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    August 29, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SYNTHES
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(4) COMPLAINT HANDLING UNIT REPORTED THE REAMER BROKE DURING SURGERY. THE PATIENT HAD A TIBIA AND FIBULA FRACTURE AND A MEDULLARY NAIL WAS IMPLANTED. DURING SURGERY, THE REAMER BLOCKED AND BROKE AT THE LEVEL OF THE DISTAL FRAGMENT. THE BROKEN REAMER FRAGMENT COULD ONLY BE RETRIEVED BY CUTTING THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49020 FLEX-SHAFT Ø9 L360 W/FIXED REAMER HEAD FLEX-SHAFT Ø9 L360 W/FIXED REAMER HTO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1