BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 4132164 · Received October 1, 2014

    Report

    Report Number
    8030965-2014-01353
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE DID NOT FUNCTION PROPERLY. VARIOUS PARTS WERE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A COMPLAINT ON TRAUMA RECON SYSTEM WITH EQUIPMENT. IN SEVERAL OCCASIONS, THE DRILL/SAW DOES NOT WORK SATISFACTORILY. DESPITE A FULLY-LOADED BATTERY, IT IS SLOW AND TIRED FROM THE START AND IT GETS OVERHEATED. METAL PINS DOWN IN THE BATTERY CASING HAVE ALSO SHIFTED MANY TIMES, SO THE BATTERY DIDN¿T GO DOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613026 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH 3691

    Patients

    Seq Age Sex Outcome Treatment
    1