BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS

    MDR report key: 7026315 · Received November 13, 2017

    Report

    Report Number
    3012447612-2017-00623
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 17, 2017
    Report Date
    April 30, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    PK132884
    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 DEVICE WAS CONFIRMED TO OUTPUT TORQUE OUTSIDE OF THE PERFORMANCE RANGE. THE CAUSE OF THIS ISSUE CANNOT BE DEFINITIVELY DETERMINED, HOWEVER HANDLES FOUND OUT OF CALIBRATION TYPICALLY EXHIBIT SPRING RELAXATION, WEAR OF CRITICAL TORQUE COMPONENTS, AND/OR BREAK DOWN OF THE INTERNAL LUBRICATION FROM USE OVER TIME. 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
    805691 MODULAR HANDLE, T RATCHETING TLR 90 IN-LBS PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM NKB ZIMMER BIOMET SPINE INC. NA 69FD-020

    Patients

    Seq Age Sex Outcome Treatment
    1