BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HANDLE, T NON-RATCHETING TORQUE LIMITING 90 IN-LB

    MDR report key: 6993640 · Received November 1, 2017

    Report

    Report Number
    3012447612-2017-00608
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 6, 2017
    Report Date
    April 27, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    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 TESTED AND CONFIRMED TO OUTPUT TORQUE OUTSIDE OF SPECIFICATIONS. THE CAUSE CANNOT BE DEFINITIVELY DETERMINED; HOWEVER, TYPICAL CAUSES INCLUDE 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
    774029 MODULAR HANDLE, T NON-RATCHETING TORQUE LIMITING 90 IN-LB SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE INC. NA 84DK-006

    Patients

    Seq Age Sex Outcome Treatment
    1