BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP

    MDR report key: 14454753 · Received May 20, 2022

    Report

    Report Number
    3009962553-2022-00001
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 19, 2022
    Manufacturer
    CLARIANCE SAS
    Product Code
    HXX
    UDI-DI
    03700780625239
    PMA / PMN Number
    K120469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TWO SHAFTS #1891040 OF THE REDUCTION POLYAXIAL SCREWDRIVER BROKE DURING SURGERY. THE TIPS BROKE OFF WHILE THE SURGEON WAS INSERTING THE SCREW AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. HOWEVER, NO PATIENT HARM WAS REPORTED, AND THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

    Additional Manufacturer Narrative · 0

    TWO SHAFTS #1891040 OF THE REDUCTION POLYAXIAL SCREWDRIVER BROKE DURING SURGERY. THE TIPS BROKE OFF WHILE THE SURGEON WAS INSERTING THE SCREW AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. HOWEVER, NO PATIENT HARM WAS REPORTED, AND THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT. THIS EVENT IS REPORTABLE AS A MALFUNCTION. ANALYSIS REPORT CONCLUSION 08/12/2022: THE TWO MAIN CAUSES OF THE SCREWDRIVER SHAFT BREAKAGE ARE DUE TO A BENDING STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY, AND TORSION STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY. THIS PARTICULAR BREAKAGE WAS CAUSED BY TORSION STRESS.

    Description of Event or Problem · 0

    THE TIPS OF THE ERISMA DRIVERS BROKE OFF WHILE THE DR. INSERTING THE REDUCTION AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. THE SAME ACTION BROKE TWO DRIVERS IN THE PERIOD OF 5 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    THE TIPS OF THE ERISMA DRIVERS BROKE OFF WHILE THE DR. INSERTING THE REDUCTION AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. THE SAME ACTION BROKE TWO DRIVERS IN THE PERIOD OF 5 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657679 ERISMA-LP ERISMA REDUCTION SCREWDRIVER SHAFT HXX CLARIANCE SAS 18911040 JAA1X 03700780625239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown