BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 10993326 · Received December 11, 2020

    Report

    Report Number
    3011137372-2020-00287
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    December 3, 2020
    Report Date
    December 3, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). DEVICE HISTORY RECORD (DHR) 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 A9 WAS RECEIVED FOR EVALUATION. THE MALLET HEAD HAS BROKEN AWAY FROM THE HANDLE. THE FRACTURE PLANE SHOWS CRACKS PARALLEL TO THE IMPACT PLANE WHICH IS ABNORMAL. THE MALLET FACE EXHIBITS DEFORMATION AND THE EDGES OF THE MALLET FACE FROM EXCESSIVE IMPACT. DAMAGE IS CONSISTENT WITH OVER STRESSING OF THE MALLET HEAD. THE MALLET FACE IS DEFORMED INDICATING THAT EXCESSIVE FORCE HAS BEEN APPLIED OFF CENTER FROM THE MALLET FACE. (1) SAMPLE OF KM46666 LOT A9 WAS RECEIVED FOR EVALUATION. THE MALLET HEAD HAS BROKEN AWAY FROM THE HANDLE. THE FRACTURE PLANE SHOWS CRACKS PARALLEL TO THE IMPACT PLANE WHICH IS ABNORMAL. THE MALLET FACE EXHIBITS DEFORMATION AND THE EDGES OF THE MALLET FACE FROM EXCESSIVE IMPACT. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666 DAMAGE IS CONSISTENT WITH OVER STRESSING OF THE MALLET HEAD. THE MALLET FACE IS DEFORMED INDICATING THAT EXCESSIVE FORCE HAS BEEN APPLIED OFF CENTER FROM THE MALLET FACE.

    Description of Event or Problem · 0

    REPORTED ISSUE: I NEED TO SEND IN A MALLET THAT BROKE DURING A CASE. THE HEAD SHEARED OFF AT HANDLE AGAIN.

    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

    REPORTED ISSUE: I NEED TO SEND IN A MALLET THAT BROKE DURING A CASE. THE HEAD SHEARED OFF AT HANDLE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454929 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1