BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF PLUG DRIVER

    MDR report key: 11832401 · Received May 17, 2021

    Report

    Report Number
    3012447612-2021-00176
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    March 3, 2021
    Report Date
    September 1, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWP
    UDI-DI
    00888480594772
    PMA / PMN Number
    K113593
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT NOT RETURNED AND PHOTOS WERE NOT PROVIDED FOR REVIEW, SO DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. IT COULD ALSO BE ATTRIBUTED TO OFF-AXIS FORCES APPLIED DURING USE. DHR REVIEW PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. 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 · 0

    IT WAS REPORTED THAT DURING SURGERY A PLUG DRIVER WAS DISCOVERED TO HAVE BROKEN DURING TORQUEING. THERE WAS NO REPORTED PATIENT IMPACT.

    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 DURING SURGERY A PLUG DRIVER WAS DISCOVERED TO HAVE A BROKEN TORQUE. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727975 HF PLUG DRIVER NEXTGEN ALTIUS OCT SYSTEM KWP ZIMMER BIOMET SPINE INC. N/A PW38N 00888480594772

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR