BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SCREW INSERTER

    MDR report key: 12059470 · Received June 24, 2021

    Report

    Report Number
    3012447612-2021-00207
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Report Date
    July 13, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    UDI-DI
    00888480580614
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN H3. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION, THE RETURNED DRIVER WAS EVALUATED AND CONFIRMED TO HAVE A BROKEN TIP. POTENTIAL CAUSE THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED AT THIS TIME SINCE THERE IS NO INFORMATION AVAILABLE REGARDING HOW THE SCREW INSERTER WAS BEING USED OR HANDLED AT THE TIME OF THE DAMAGE. DHR REVIEW PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DEVICE USE THE 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 TWO FRACTURED SCREW INSERTERS, A DEFORMED PLUG DRIVER, AND A DEFORMED SCREWDRIVER ASSEMBLY WERE FOUND. THEY WERE DISCOVERED OUTSIDE OF SURGERY WITH NO PATIENT PRESENT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    REFERENCE REPORTS 3012447612-2021-00207 TO 3012447612-2021-00210. 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 TWO FRACTURED SCREW INSERTERS, A DEFORMED PLUG DRIVER, AND A DEFORMED SCREWDRIVER ASSEMBLY WERE FOUND. THEY WERE DISCOVERED OUTSIDE OF SURGERY WITH NO PATIENT PRESENT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952868 CYPHER SCREW INSERTER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. N/A PY122A 00888480580614

    Patients

    Seq Age Sex Outcome Treatment
    1