BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3561882 · Received January 8, 2014

    Report

    Report Number
    8030965-2013-05059
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    July 8, 2013
    Report Date
    August 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COORDINATED BY SYNTHES ANSPACH. THE REPORT RECEIVED INDICATES THE CUSTOMERS COMPLAINT THAT THE UNIT DOES NOT FUNCTION WAS CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WAS DUPLICATED. THE EVIDENCE INDICATES THIS IS DUE TO USAGE AND WEAR OVER TIME. (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE LOT #(1429) PROVIDED IN THE INITIAL MEDWATCH IS A SUPPLIER LOT#. THE SYNTHES LOT# IS; 5043580. PLACEHOLDER.

    Description of Event or Problem · 1

    THE FACILITY STATED, A SMALL BATTERY DRIVE DOES NOT WORK. THE PRODUCT WAS LEFT IN A REPAIR BOX WITH NO ADDITIONAL INFORMATION. IT WAS REPORTED THAT THERE IS NO USER OR PATIENT INJURY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12610 SMALL BATTERY DRIVE HWE SYNTHES GMBH 1429

    Patients

    Seq Age Sex Outcome Treatment
    1