BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-AXIAL SCREW INSERTER, UNIVERSAL (POLARIS 5.5)

    MDR report key: 14463431 · Received May 20, 2022

    Report

    Report Number
    3012447612-2022-00140
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Report Date
    September 23, 2022
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    UDI-DI
    00880304876583
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. REFERENCE REPORTS 3012447612-2022-00139 THROUGH 3012447612-2022-001142.

    Additional Manufacturer Narrative · 0

    CORRECTIONS : UDI NUMBER . ADDITIONAL INFORMATION : COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: POLARIS INSERTERS (4 EACH OF PN 14-500185) ARE ALL MISSING THE ALIGNMENT BLOCK. ROOT CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THESE FAILURES COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. DHR REVIEW: PER DHR REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMVIE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL INSTRUMENTS WERE FOUND TO BE DAMAGED DURING A ROUTINE INSPECTION. NO SPECIFIC PATIENT OR SURGICAL INFORMATION IS KNOWN. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL INSTRUMENTS WERE FOUND TO BE DAMAGED DURING A ROUTINE INSPECTION. NO SPECIFIC PATIENT OR SURGICAL INFORMATION IS KNOWN. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764426 MULTI-AXIAL SCREW INSERTER, UNIVERSAL (POLARIS 5.5) SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. NA PV114A 00880304876583

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown