BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3123459 · Received May 22, 2013

    Report

    Report Number
    8030965-2013-02302
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. 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 #:8030965-2013-02302. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING AN ORTHOPEDIC SURGERY ON (B)(6) 2013, REPORTEDLY THERE WAS AN UNSTEADY TRIGGER ON THE SMALL BATTERY DRIVE. NO INJURIES OR MEDICAL INTERVENTION WAS REPORTED. A SPARE SMALL BATTERY DRIVE WAS AVAILABLE FOR USE. IT WAS REPORTED NO PATIENT INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225947 SMALL BATTERY DRIVE HWE SYNTHES GMBH 001409

    Patients

    Seq Age Sex Outcome Treatment
    1