BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUG DRIVER

    MDR report key: 6989194 · Received October 30, 2017

    Report

    Report Number
    3012447612-2017-00593
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 2, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED DRIVER WAS EVALUATED. THE TIP WAS CONFIRMED TO HAVE TWISTED. THE CAUSE IS UNABLE TO BE DETERMINED SINCE IT IS UNKNOWN HOW THE DEVICE WAS BEING HANDLED OR USED AT THE TIME THE DEFORMATION OCCURRED. 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. REFERENCE REPORT 3012447612-2017-00592.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PLUG DRIVER WAS FOUND TO BE BROKEN AND ANOTHER PLUG DRIVER WAS FOUND WITH A TWISTED TIP DURING SURGERY. BECAUSE OF THIS, THE DRIVERS COULD NOT BE USED, RESULTING IN THE PLUGS NOT BEING ABLE TO BE FINAL TIGHTENED WITH A TORQUE HANDLE TO ENSURE ENOUGH TORQUE WAS PLACED ON THEM TO SECURE THEM INTO PLACE. THERE HAVE BEEN NO PATIENT IMPACTS REPORTED AS A RESULT OF THIS EVENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768562 PLUG DRIVER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. NA ZB120801

    Patients

    Seq Age Sex Outcome Treatment
    1