BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3131799 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02462
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO THE COMPLAINT NOT MEETING THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT #: 8030965-2013-02462.

    Description of Event or Problem · 1

    THIS IS A VETERINARY EVENT. FACILITY REPORTS THAT DURING AN ORTHOPEDIC SURGERY ON A CANINE ON (B)(6) 2013, A SMALL BATTERY DRIVE WOULD NOT RUN EVEN WITH CHANGED BATTERIES. THERE WAS A 5-10 MINUTE DELAY IN SURGERY. A SPARE SMALL BATTERY DRIVE WAS USED TO COMPLETE SURGERY SUCCESSFULLY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. ALL AVAILABLE EVENT INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236803 SMALL BATTERY DRIVE HWE SYNTHES GMBH 004352

    Patients

    Seq Age Sex Outcome Treatment
    1