BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2014-01015

    MDR report key: 4143486 · Received October 6, 2014

    Report

    Report Number
    2520274-2014-01015
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    May 29, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    MOQ
    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 SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE BATTERY REAMER/DRILL AND BATTERY CASING WERE RETURNED FOR REPAIR BECAUSE THEY WERE NOT WORKING. DRILL'S ELECTRONIC CONTROL UNIT WAS UNRESPONSIVE AND THE BATTERY HOUSING SEAL WAS WORN AND DEFORMED. THIS IS REPORT 2 OF 2 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622922 MOQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1