BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG MAS BUTTON LOCK INSERTER

    MDR report key: 11724299 · Received April 26, 2021

    Report

    Report Number
    3012447612-2021-00117
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 29, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE INSPECTION: THE RETURNED PRODUCT MATCHES INFORMATION LISTED IN THE COMPLAINT FILE. VISUAL INSPECTION OF THE DEVICE REVEALS THAT IT IS FRACTURED AS REPORTED. 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 ZIMMER BIOMET¿S CONTROL. POTENTIAL 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. DEVICE USAGE: 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 A SCREWDRIVER CRACKED DURING SCREW INSERTION INTRA-OPERATIVELY. ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY REPORTED PATIENT IMPACTS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREWDRIVER CRACKED DURING SCREW INSERTION INTRA-OPERATIVELY. ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY REPORTED PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624605 LONG MAS BUTTON LOCK INSERTER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. N/A 307944

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR