BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREPAN-MOTOR

    MDR report key: 14940211 · Received July 6, 2022

    Report

    Report Number
    3013886523-2022-00290
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Report Date
    August 9, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    FRO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PRODUCT SAMPLE WAS RETURNED FOR EVALUATION: DHR - NO DISCREPANCIES WERE NOTED. FAILURE ANALYSIS - THE INVESTIGATION DETECTED THAT THE BAYONNET SLEEVE IS DEFORMED. THE BAYONNET SLEEVE AND THE INNER PART AT HOSE COUPLING HAVE BEEN EXCHANGED. THE ROOT CAUSE OF THE DEFECTIVE DEVICE IS DUE TO A BAD HANDLING FROM THE USER AS THE DEVICE HAS PROBABLY BEEN DROPPED TO THE FLOOR.

    Description of Event or Problem · 0

    A FACILITY REPORTED THE CONNECTOR OF A TREPAN-MOTOR (ID 935003) IS MECHANICALLY DEFECTIVE. ISSUE DETECTED PRE-OPERATIVELY, NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967462 TREPAN-MOTOR OTHER CRANIAL PRODUCTS FRO INTEGRA LIFESCIENCES MANSFIELD 63341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown