BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5/32 IN (4MM) HEX FINAL DRIVER

    MDR report key: 7026796 · Received November 13, 2017

    Report

    Report Number
    3012447612-2017-00637
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 27, 2017
    Report Date
    May 11, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED DRIVER WAS EXAMINED. THERE WERE INDICATIONS OF USE INCLUDING WORN HEX CORNERS AND SCRATCHES ON THE QUICK CONNECT END. A FUNCTIONAL EVALUATION FOUND THE DEVICE TO MAINTAIN ITS FUNCTIONALITY. THE CAUSE IS LIKELY ATTRIBUTED TO WEAR FROM REPETITIVE USE. 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 A FINAL DRIVER WAS FOUND WORN OUTSIDE OF SURGERY AND DID NOT HAVE ANY SURGICAL OR PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804347 5/32 IN (4MM) HEX FINAL DRIVER SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE INC. NA 86GA

    Patients

    Seq Age Sex Outcome Treatment
    1