BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3220815 · Received July 11, 2013

    Report

    Report Number
    1719045-2013-01774
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    August 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GZL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THIS REPORT IS PART OF THE SERVICE AND REPAIR DOCUMENTATION REMEDIATION. DEVICES THAT WERE RECEIVED BY SERVICE AND REPAIR HAVE EITHER BEEN REPAIRED AND RETURNED TO THE CUSTOMER OR DISCARDED BY SYNTHES, MAKING FURTHER PRODUCT EVALUATION BY MANUFACTURING OR ENGINEERING IMPOSSIBLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RETURNED BECAUSE THE DEVICE KEEPS RUNNING WHEN CONNECTED TO THE BATTERY. THE PRODUCT WAS RECEIVED AT SERVICE AND REPAIR WHO WAS ABLE TO REPAIR THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT. IF ANY OTHER INFORMATION IS RECEIVED THIS WILL BE REPORTED VIA A SUPPLEMENT.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES THAT A HAND PIECE FOR BATTERY POWERED DRIVER KEEPS RUNNING WHEN CONNECTED TO BATTERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320896 HAND PIECE FOR BATTERY POWERED DRIVER GZL SYNTHES MONUMENT 5763335

    Patients

    Seq Age Sex Outcome Treatment
    1