BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 3 LB / 2 LB

    MDR report key: 10425631 · Received August 19, 2020

    Report

    Report Number
    3011137372-2020-00174
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 30, 2020
    Report Date
    July 30, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46667. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. NO CONFIRMED COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46667. ISOLATED INCIDENT WITH NO SAMPLE AND NO COMPLAINT HISTORY IN RANGE. THE DEVICE WILL BE REVIEWED AND REINVESTIGATED IF RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEAD BROKE AWAY FROM THE HANDLE IN USE. THERE WAS NO PATIENT HARM OR INJURY.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD BROKE AWAY FROM THE HANDLE IN USE. THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893459 ORTHO. MALLET 3 LB / 2 LB MALLET HXL TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1