BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL TORQUE WRENCH

    MDR report key: 3040128 · Received April 3, 2013

    Report

    Report Number
    1226188-2013-00026
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THIS IS THE FIRST REPORTED COMPLAINT OF ANY TORQUE WRENCH BREAKING AT THE TIP. A REVIEW OF THE RETURNED INSTRUMENTS CONFIRMS THAT THE TIP IS BROKEN OFF OF ONE TORQUE WRENCH AT THE CONNECTION POINT TO THE LOWER TORQUE SHAFT. THE OTHER RETURNED TORQUE WRENCH IS BROKEN OFF BELOW THE CONNECTION POINT, WITH THE TIP REMAINING IN THE NECK BOLT. THE INSPECTION RECORDS WERE REVIEWED AND THERE WERE NO DEVIATIONS OR DEFECTS REPORTED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT TWO TORQUE WRENCHES BROKE WHEN THE SURGEON WAS ATTEMPTING TO REMOVE A THR NECK BOLT. THE BOTTOM PORTION OF THE TORQUE WRENCH BROKE OFF AND COULD NOT BE REMOVED FROM THE HEX PORTION OF THE NECK BOLT. AS A RESULT, THE STEM/NECK ASSEMBLY HAD TO BE REMOVED AND REPLACED WITH A NEW STEM AND NECK. A 45 MINUTE DELAY IN SURGERY OCCURRED AS A RESULT OF THE BROKEN TORQUE WRENCHES AND REMOVAL OF THE STEM/NECK ASSEMBLY. THE PATIENT'S CONDITION POST-SURGERY WAS REPORTED AS EXCELLENT. THE EXPLANTED THR COMPONENTS WERE RETURNED TO OMNI FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136909 SMALL TORQUE WRENCH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT KWQ OMNLIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR