BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 12569041 · Received October 4, 2021

    Report

    Report Number
    3011137372-2021-00264
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 23, 2021
    Report Date
    September 23, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    UDI-DI
    24026704272222
    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 WAS RECEIVED FOR EVALUATION WITH LOT # J9. VISUAL REVIEW OF THE DEVICE NOTED IMPACT MARKS ON THE EDGE OF THE MALLET FACE WITH OFF CENTER STRIKING. THE MALLET HEAD HAS SHEARED FROM THE HANDLE. THE DEVICE IS NOT FUNCTIONAL IN CURRENT STATE. THE RECENT SAMPLES FOR BROKEN HANDLES WILL BE SENT TO THE EIC FOR REVIEW WITH THE SUPPLIER. (1) SAMPLE OF KM46666 WAS RECEIVED FOR EVALUATION WITH LOT # J9. VISUAL REVIEW OF THE DEVICE NOTED IMPACT MARKS ON THE EDGE OF THE MALLET FACE WITH OFF CENTER STRIKING. THE MALLET HEAD HAS SHEARED FROM THE HANDLE. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. THE DEVICE IS NOT FUNCTIONAL IN CURRENT STATE. A SMALL NUMBER OF COMPLAINTS HAVE BEEN RECEIVED ACROSS MULTIPLE LOTS. E6, A9, F9, D4, J9, 20032366, 20033862, 20034170, 20037331, 20037516, 20039172, 20039509, 20039579, 20040182, 20040251 SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666. NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME, BUT THE FAILED DEVICES WILL BE REVIEWED WITH THE SUPPLIER TO MAKE THEM AWARE.

    Description of Event or Problem · 0

    NO INJURIES, PATIENT UNHARMED, HEAD SHEARED OFF AT JUNCTION OF HANDLE.

    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

    NO INJURIES, PATIENT UNHARMED, HEAD SHEARED OFF AT JUNCTION OF HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469958 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL IPN013965 UNKNOWN 24026704272222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown