BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISOLA

    MDR report key: 299511 · Received October 6, 2000

    Report

    Report Number
    1526439-2000-00021
    Event Type
    Other
    Date Received
    October 6, 2000
    Report Date
    October 6, 2000
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    GFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEPUY ACROMED REC'D A BROKEN ISOLA HEX DRIVER. THE TIP OF THE INSTRUMENT BROKE OFF INTO THE SET SCREW DURING FINAL TIGHTENING. THE TIP STILL REMAINS IN IMPLANT. A CHEMICAL ANALYSIS WAS PERFORMED ON THE DRIVER AND IT CONFORMED TO 420-GRADE STAINLESS STEEL. A ROCKWELL HARDNESS TEST WAS ALSO PERFORMED ON THE DRIVER AND THE DRIVER CONFORMED TO SPECS OF 54-56 HRC. THE CAUSE OF THE BROKEN TIP IS USUALLY DUE TO OVER-TIGHTENING DURING SCREW INSERTION. THESE DEVICES ARE EXTREMELY SMALL, AND WILL FRACTURE IF OVER-TORQUED. CARE MUST BE TAKEN NOT TO OVER-TORGUE THESE DRIVERS. A TORQUE WRENCH IS AVAILABLE FOR THOSE PHYSICIANS HAVING DIFFICULTY WITH THESE TYPES OF EVENTS. NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLA HEX DRIVER GFC DEPUY ACROMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other