BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3962673 · Received July 29, 2014

    Report

    Report Number
    8030965-2014-00444
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    October 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) 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. (B)(6). 510K#, DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTED THAT UNIT DID NOT FUNCTION PROPERLY DUE TO NORMAL WEAR. DEVICE REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THAT A COLIBRI HAND PIECE DID NOT WORK DURING A SURGERY. THIS IS REPORT 1 OF 1 FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440824 SMALL BATTERY DRIVE ERL SYNTHES GMBH 8372

    Patients

    Seq Age Sex Outcome Treatment
    1