BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINICA BALLED END HEX DRIVER

    MDR report key: 6911883 · Received October 3, 2017

    Report

    Report Number
    3012447612-2017-00532
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 6, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DRIVER WAS EVALUATED. THERE WERE NO SIGNS OF DAMAGE AND A FUNCTIONAL TEST WITH MATING IMPLANTS FOUND THE DRIVER TO FUNCTION AS EXPECTED. THERE WERE NO INDICATIONS OF A FAILURE ON THIS DEVICE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH MIGHT HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING DRIVER WAS GETTING STUCK/STICKING INSIDE THE PLATE WITHIN SURGERY. AN ALTERNATIVE DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692471 TRINICA BALLED END HEX DRIVER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. NA 6262696

    Patients

    Seq Age Sex Outcome Treatment
    1