BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSURE

    MDR report key: 6766733 · Received August 4, 2017

    Report

    Report Number
    1219602-2017-00853
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 29, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES ARE NOT BEING RETURNED FOR EVALUATION. THE BIOSURE SCREWS IFU (10600361) INSTRUCTS THE END USER TO INSPECT THE TIP OF THE DRIVER AND IF TIP FLARING IS APPARENT DO NOT USE THE DRIVER, IT ALSO INSTRUCTS THE END USER TO ASSURE THAT THE DRIVER IS PARALLEL TO THE TUNNEL AVOIDING OFF AXIS INSERTION. ADDITIONALLY THE DRIVERS IFU (1060355) INSTRUCTS THE END USER TO INSPECT THE DEVICE TO ENSURE IT IS NOT DAMAGED. DO NOT USE A DAMAGED DEVICE. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MANY (AN UNSPECIFIED NUMBER) OF BIOSURE SCREWS HAVE BEEN BROKEN OFF INTRAOPERATIVELY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549580 BIOSURE SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1