BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 12306839 · Received August 11, 2021

    Report

    Report Number
    3011137372-2021-00215
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 9, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 KM46666. (1) SAMPLE OF KM46666 LOT J9 (OCT 2019) WAS RECEIVED FOR EVALUATION WITH A BROKEN/DETACHED MALLET HEAD. THE MALLET WAS IS LIGHTLY DEFORMED WITH EVEN AN EVEN WEAR PATTERN ACROSS THE MALLET FACE. THE FRACTURE PLANES OF THE HANDLE AND MALLET HEAD WERE INSPECTED. A FOREIGN SUBSTANCE WAS FOUND ON THE HANDLE SIDE OF THE MALLET. THE FOREIGN MATERIAL WAS PEELED AWAY FROM THE FRACTURE PLANE AND INSPECTED UNDER MAGNIFICATION. THE MATERIAL IS WHITE AND PLIABLE WITH CHARACTERISTICS OF A THERMOPLASTIC. THE PRESENCE OF THIS PLASTIC INHIBITED MATCHING OF THE FRACTURE PLANE WHICH SUGGESTS THAT IT APPEARED AFTER THE INITIAL DAMAGE OCCURED. THE ORIGIN OF THIS MATERIAL COULD NOT BE DETERMINED. THE APPEARANCE OF THIS SUBSTANCE MAY HAVE APPEARED AFTER THE FAILURE OF THE MALLET. GIVEN THE NATURE OF THE DEVICE IT IS DIFFICULT TO DETERMINE WHETHER THIS IS THE RESULT OF UNDUE FORCE. PREVIOUS COMPLAINTS HAVE EXHIBITED EXCESSIVE DAMAGE TO THE MALLET FACE. THIS SPECIFIC COMPLAINT LACKS THE PHYSICAL DAMAGE OBSERVED IN PRIOR COMPLAINTS AND WILL BE RETAINED FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    INSTRUMENT BROKE DURING A CASE, THE HEAD SHEARED OFF THE HANDLE.

    Additional Manufacturer Narrative · 1

    (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

    INSTRUMENT BROKE DURING A CASE, THE HEAD SHEARED OFF THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206446 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL KM46-666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown