BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3132592 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02416
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE WITHIN THE LAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(6). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED FOR EVALUATION. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE REPORTERS 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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2013; THE TRIGGER OF THE SMALL BATTERY DRIVE WAS STICKING AND THE DEVICE WAS CONTINUOUSLY RUNNING. IT WAS ALSO REPORTED THE EVENT CAUSED A DELAY IN PROCEDURE BY APPROXIMATELY FIVE MINUTES WHILE THE SURGEON SWITCHED TO ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENT TO PATIENT. THIS REPORT IS FOR A SMALL BATTERY DRIVE. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236697 SMALL BATTERY DRIVE HWE SYNTHES GMBH 001971

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR