BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 4143488 · Received October 6, 2014

    Report

    Report Number
    8030965-2014-01253
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    May 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    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 (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 CONTROL UNIT WAS NOT FUNCTIONING, A BATTERY MELTED, AND THE BATTERY HOUSING SEAL WAS WORN AND DEFORMED. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 06/06/2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE BATTERY REAMER/DRILL AND BATTERY CASING WERE RETURNED FOR REPAIR BECAUSE THEY WERE NOT WORKING. THE DRILL'S ELECTRONIC CONTROL UNIT WAS UNRESPONSIVE AND THE BATTERY HOUSING SEAL WAS WORN AND DEFORMED. THIS IS REPORT 1 OF 2 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622403 BATTERY REAMER/DRILL MOQ SYNTHES GMBH 3281

    Patients

    Seq Age Sex Outcome Treatment
    1