BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/REAMER

    MDR report key: 5694857 · Received June 2, 2016

    Report

    Report Number
    3003604053-2016-00019
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 9, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KFK
    PMA / PMN Number
    K870157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES.

    Additional Manufacturer Narrative · 1

    NO EVALUATION CONDUCTED TO DATE, AWAITING RECEIPT OF DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WOULD NOT POWER ON. THERE WAS NO BACKUP DEVICE AVAILABLE AND A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350992 DRILL/REAMER SAW, PNEUMATICALLY POWERED KFK SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1