BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS

    MDR report key: 6911935 · Received October 3, 2017

    Report

    Report Number
    3012447612-2017-00534
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 6, 2017
    Report Date
    March 28, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXC
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED HANDLE WAS EVALUATED. THE TORQUE OUTPUT WAS CONFIRMED TO BE BELOW THE ACCEPTABLE LIMIT. THE CAUSE CANNOT BE DEFINITIVELY DETERMINED, BUT TYPICAL CONTRIBUTORS INCLUDE SPRING RELAXATION, WEAR TO CRITICAL COMPONENTS, AND A BREAKDOWN OF INTERNAL LUBRICATION OVER MULTIPLE USES. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TORQUE OUTPUT OF A TORQUE LIMITING HANDLE WAS FOUND OUTSIDE OF THE ADEQUATE PERFORMANCE RANGE. THIS WAS DETECTED DURING A PRELIMINARY CALIBRATION CHECK BY ZIMMER BIOMET SPINE PERSONNEL. THERE ARE NO SPECIFIC SURGICAL PROCEDURES ASSOCIATED WITH THIS HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692364 MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXC ZIMMER BIOMET SPINE INC. NA 86KC-086

    Patients

    Seq Age Sex Outcome Treatment
    1