BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 4093512 · Received September 16, 2014

    Report

    Report Number
    8030965-2014-01361
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE MOTOR WAS SEIZED, NO LONGER OPERATIONAL. THE CONTROL UNIT (ECU) WAS DEGRADED WITH NOTICEABLE DIRT AND RUST ON THE INSIDE. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(4) 2012. THE COMPLAINT IS INDETERMINATE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE WAS OVERHEATING CAUSING AN OPERATIONAL FAILURE. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572562 SMALL BATTERY DRIVE MOQ SYNTHES GMBH 3716

    Patients

    Seq Age Sex Outcome Treatment
    1