BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA FINAL DRIVER

    MDR report key: 16438629 · Received February 24, 2023

    Report

    Report Number
    3012447612-2023-00050
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Report Date
    June 17, 2024
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    GFC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H4 AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE RETURNED DEVICES MATCH THE INFORMATION IN THE COMPLAINT FILE AND WERE EXAMINED. VISUAL INSPECTION REVEALED THAT THE TIPS OF BOTH FINAL DRIVERS WERE DEFORMED/ROUNDED DOWN. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. 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 HIGHRIDGE MEDICAL¿S CONTROL. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    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 3012447612-2023-00049.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WAREHOUSE FOUND TWO SEQUOIA DRIVERS WITH DEFORMED TIPS DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WAREHOUSE FOUND TWO SEQUOIA DRIVERS WITH DEFORMED TIPS DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933853 SEQUOIA FINAL DRIVER DRIVER GFC ZIMMER BIOMET SPINE INC. NA 70CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose