BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM ANGLE ATTACHMENT

    MDR report key: 7063585 · Received November 28, 2017

    Report

    Report Number
    1045834-2017-50034
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    October 30, 2017
    Report Date
    October 30, 2017
    Manufacturer
    THE ANSPACH EFFORT LLC
    Product Code
    HBC
    UDI-DI
    00845384007159
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE OVERHEATING AT THE BEARINGS IN THE TIP 119 DEGREES. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS ALSO NOTED THAT THE ROOT CAUSE OF THE HEAT WAS FROM WORN OUT BEARINGS AND THE COMPONENT DAMAGE WAS CAUSED FROM NORMAL USE AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS HEATING UP. 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
    844959 7.5CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC THE ANSPACH EFFORT LLC QD8-S 00845384007159

    Patients

    Seq Age Sex Outcome Treatment
    1