BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP MIS

    MDR report key: 11453367 · Received March 10, 2021

    Report

    Report Number
    3009962553-2021-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 22, 2021
    Manufacturer
    CLARIANCE SAS
    Product Code
    HXX
    UDI-DI
    03700780627271
    PMA / PMN Number
    K162367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT - ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS LIKELY NOT REPORTABLE, THE COMPANY HAS DECIDED TO FILE THIS MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. SUPPLEMENTAL REPORT - AS THIS ISSUE WAS NOTICED POST-SURGERY-STERILIZATION, IT IS UNSURE AS TO WHEN THE SCREWDRIVER TIP BROKE. THE COMPANY HAS DECIDED TO FILE AN MDR OUT OF AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, WHICH CONCLUDED THAT THE TWO MAIN CAUSES OF SCREWDRIVER SHAFT BREAKAGE ARE DUE TO A BENDING STRESS APPLIED TO THE INSTRUMENT DURING SURGERY, AND TORSION STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON SURING SURGERY.

    Description of Event or Problem · 0

    AFTER STERILIZATION HAD BEEN COMPLETED AND THE INSTRUMENTS WERE BEING PUT BACK INTO THE TRAYS IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. THE TIP WAS NOT LOCATED, AND IT IS UNSURE WHEN THE BREAKAGE OCCURRED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS LIKELY NOT REPORTABLE, THE COMPANY HAS DECIDED TO FILE THIS MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803.

    Description of Event or Problem · 1

    AFTER STERILIZATION HAD BEEN COMPLETED AND THE INSTRUMENTS WERE BEING PUT BACK INTO THE TRAYS IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. THE TIP WAS NOT LOCATED, AND IT IS UNSURE WHEN THE BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354615 ERISMA-LP MIS SCREWDRIVER SHAFT HXX CLARIANCE SAS 13911009 JA01N 03700780627271

    Patients

    Seq Age Sex Outcome Treatment
    1