BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL DRIVER

    MDR report key: 7026808 · Received November 13, 2017

    Report

    Report Number
    3012447612-2017-00638
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 25, 2017
    Report Date
    May 30, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED DRIVER WAS EVALUATED. THE TIP WAS FOUND TO HAVE TWISTED UNTIL FRACTURE. THE CAUSE IS LIKELY ATTRIBUTED TO FORCES PLACED ON THE DRIVER DURING USE WHICH EXCEEDED THE DEVICE'S CAPABILITIES. A DESIGN ENHANCEMENT WAS PUT INTO PLACE AFTER THE MANUFACTURE OF THIS DEVICE TO INCREASE THE STRENGTH OF THE TIP. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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 TIP OF A FINAL DRIVER BROKE OFF DURING SURGERY. THE TIP WAS REMOVED FROM THE SET SCREW USING BONE WAX SO THE PATIENT DID NOT RETAIN A FOREIGN BODY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DRIVER. THERE WERE NO REPORTED PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805139 FINAL DRIVER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. NA 62594498

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR