BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED T-HANDLE BONE AWL II

    MDR report key: 1053635 · Received May 22, 2008

    Report

    Report Number
    1649384-2008-00245
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MANUFACTURE IS UNKNOWN. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY, THE T-HANDLE AWL BROKE IN TWO PIECES WHEN THE DOCTOR WAS USING IT TO PREPARE THE PEDICLE. ADDITIONAL INFORMATION RECEIVED ON 29 APR 2008 VIA TELEPHONE, THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY, THE SURGEON WAS USING THE AWL TO PREPARE THE LAST PEDICLE WHEN THE AWL BROKE IN TWO. THE SURGEON THEN REMOVED THE FIRST PIECE, AND THEN RETRIEVED THE OTHER PIECE THAT WAS STUCK IN THE BONE. THE SURGEON THEN PLACED THE SCREW IN THE HOLE AND FINISHED THE CASE. THIS EXTENDED SURGICAL TIME BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED T-HANDLE BONE AWL II PATHFINDER HWJ ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R