BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLASSIC SCREWDRIVER

    MDR report key: 11842498 · Received May 18, 2021

    Report

    Report Number
    3012447612-2021-00183
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 17, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    UDI-DI
    00889024336377
    PMA / PMN Number
    K132884
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION: THE RETURNED DEVICES MATCH THE INFORMATION IN THE COMPLAINT FILE AND WERE EXAMINED. VISUAL INSPECTION REVEALED THAT THE DRIVER HAS A FRACTURED TIP. DHR REVIEW: THE DHR WAS REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET¿S CONTROL. POTENTIAL ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. AN OFF-AXIS FORCE APPLIED DURING SURGERY OR WEAR AND TEAR FROM MULTIPLE USES AND STERILIZATION CYCLES MAY HAVE CONTRIBUTED TO THIS EVENT. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER WAS FOUND TO HAVE FRACTURED OFF DURING A ROUTING INSPECTION. THERE WAS NOT A PATIENT PRESENT AT THE TIME OF DISCOVERY.

    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 A SCREWDRIVER CAN NO LONGER RETAIN ITS SCREW. THIS WAS DISCOVERED DURING ROUTINE INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739767 CLASSIC SCREWDRIVER PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM NKB ZIMMER BIOMET SPINE INC. N/A 62ZD 00889024336377

    Patients

    Seq Age Sex Outcome Treatment
    1