BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORCI DRIVER

    MDR report key: 341150 · Received July 3, 2001

    Report

    Report Number
    1219602-2001-00063
    Event Type
    Malfunction
    Date Received
    July 3, 2001
    Date of Event
    May 17, 2001
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION RECEIVED A REPORT THAT THE SURGEON EXPERIENCED DIFFICULTY WITH THE USE OF A BIORCI DRIVER DURING MORE THEN ONE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE BIORCI DRIVER WAS NOT ENGAGING COMPLETELY WITH THE BIORCI SCREWS. TWO OUT OF FIVE OF THE BIORCI SCREWS BROKE. A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30086 BIORCI DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXX SMITH & NEPHEW, INC. ENDOSCOPY DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN