BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3132649 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02862
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTER'S COMPLAINT OF A STICKY TRIGGER WAS CONFIRMED. THE SMALL BATTERY DRIVE DRILL WAS TESTED AND THE COMPLAINT WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME.

    Additional Manufacturer Narrative · 1

    A SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 21-FEB-2013 DUE TO WILL NOT RUN. A SERVICE REQUEST FOR THIS ITEM WAS CALLED IN ON 1-MAY-2013 FOR STICKY TRIGGER. THE PREVIOUS SERVICE CONDITION OF WILL NOT RUN IS NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF STICKY TRIGGER. (B)(4)

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2013, IT WAS DISCOVERED THE TRIGGER ON THE SMALL BATTERY DRIVE WAS STICKING. IT IS REPORTED THE PROCEDURE WAS DELAYED APPROXIMATELY 10 TO 20 MINUTES WHILE A SPARE DEVICE WAS RETRIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236474 SMALL BATTERY DRIVE HWE SYNTHES USA 001832

    Patients

    Seq Age Sex Outcome Treatment
    1