BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-AXIAL SCREW INSERTER, UNIVERSAL (POLARIS 5.5)

    MDR report key: 11885917 · Received May 26, 2021

    Report

    Report Number
    3012447612-2021-00192
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    June 7, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    UDI-DI
    00880304876583
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION ADDED TO H6: COMPONENT CODES, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS CORRECTED INFORMATION IN H3 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND INITIALLY CORRECTED INFORMATION. SUMMARY THE COMPLAINT IS UNCONFIRMED FOR ONE (1) OF ONE (1) RETURNED POL 5.5 TI MAXL SCR INSRT UNIV (PN (B)(4). ) FOR THE FAILURE OF TIP BEING STRIPPED.DEVICE PART NUMBER(B)(4). WAS FOUND TO HAVE SIGNS OF USE, HOWEVER NO DAMAGE WAS NOTED. A FUNCTIONAL TEST WAS PERFORMED WITH A MATING POLARIS SCREW AND FOUND THAT THE INSERTER WAS ABLE TO ASSEMBLE AND DISASSEMBLE FROM THE SCREW AS EXPECTED. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. POTENTIAL CAUSE THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED AT THIS TIME SINCE THERE IS NO INFORMATION AVAILABLE REGARDING HOW THE INSTRUMENTS WERE BEING USED OR HANDLED AT THE TIME OF THE DAMAGE. DHR REVIEW AND RELATED ACTIONS PER DHRS REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE THIS DEVICES ARE USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DAMAGED TORQUE WRENCH AND A DAMAGED SCREW INSERTER WERE FOUND IN OFFICE OUTSIDE OF SURGERY. THERE WAS NO PATIENT PRESENT AT THE TIME OF DISCOVERY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 REPORT 3012447612-2021-00191.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DAMAGED TORQUE WRENCH AND A DAMAGED SCREW INSERTER WERE FOUND IN OFFICE OUTSIDE OF SURGERY. THERE WAS NO PATIENT PRESENT AT THE TIME OF DISCOVERY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781199 MULTI-AXIAL SCREW INSERTER, UNIVERSAL (POLARIS 5.5) SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. N/A P1809C 00880304876583

    Patients

    Seq Age Sex Outcome Treatment
    1