BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 3203705 · Received July 3, 2013

    Report

    Report Number
    1045834-2013-02668
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE INDICATES THIS IS DUE TO IMPROPER HANDLING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "DRILL WAS JAMMED AND WOULD NOT RELEASE THE LOCKING MECHANISM" ON THE COMPACT SPEED REDUCER DEVICE. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY.  IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE.  IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED.  SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306053 PERFORATOR DRIVER W/HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)-COMPACT SPEED REDUCER HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1