BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 2974906 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-01150
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 A SMALL BATTERY DRIVE WAS INCONSISTENT OR INTERMITTENT. THE SYMPTOM WAS DETECTED PRIOR TO SURGERY AND THEN TRANSFERRED TO STERILE PROCESSING. THE PRODUCT WAS NOT USED IN SURGERY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78540 SMALL BATTERY DRIVE SMALL BATTERY DRIVE HWE SYNTHES USA 002148

    Patients

    Seq Age Sex Outcome Treatment
    1