BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 13012648 · Received December 15, 2021

    Report

    Report Number
    1045834-2021-01904
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    July 6, 2021
    Report Date
    November 4, 2021
    Manufacturer
    THE ANSPACH EFFORT LLC
    Product Code
    ERL
    UDI-DI
    00845384003571
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE DEVICE HAD BEARING DAMAGE AND HEAT. THEREFORE, THE REPORTED CONDITION THAT THE DEVICE WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE TRACED TO COMPONENT FAILURE DUE TO WEAR. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD BEARING DAMAGE, THE LABELING WAS DAMAGED, A CUTTER COULD NOT BE INSERTED, HEAT, AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VISUAL ASSESSMENT, CUTTER INSERTION, VIBRATION ASSESSMENT, AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD BEARING DAMAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910815 11.0 CM LONG ATTACHMENT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) ERL THE ANSPACH EFFORT LLC LONG 00845384003571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown