BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 9552887 · Received January 6, 2020

    Report

    Report Number
    3011137372-2020-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 17, 2019
    Report Date
    December 17, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(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 (B)(4). (B)(4). SAMPLE OF (B)(4). LOT A9 WAS RECEIVED FOR EVALUATION. THE HEAD OF THE MALLET HAS SEPARATED FROM THE HANDLE IN A BIDIRECTIONAL FRACTURE PLANE. THERE IS SEVERE DEFORMATION PRESENT FROM REPEATED STRIKING WHICH HAS ROUNDED OVER AND "MUSHROOMED" THE EDGES OF THE MALLET FACE. THE DEVICE IS NOT FUNCTIONAL IN CURRENT STATE. DESPITE THE A9 LOT NUMBER (JAN 2019) THE MALLET EXHIBITS HEAVY AND EXCESSIVE USAGE. THE USEFUL LIFE HAS BEEN EXCEEDED. (B)(4). SAMPLE OF (B)(4). LOT A9 WAS RECEIVED FOR EVALUATION. THE HEAD OF THE MALLET HAS SEPARATED FROM THE HANDLE IN A BIDIRECTIONAL FRACTURE PLANE. THERE IS SEVERE DEFORMATION PRESENT FROM REPEATED STRIKING WHICH HAS ROUNDED OVER AND "MUSHROOMED" THE EDGES OF THE MALLET FACE. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. THE DEVICE IS NOT FUNCTIONAL IN CURRENT STATE. A PREVIOUS COMPLAINT EXISTS FROM THE SAME CUSTOMER - REFERENCE(B)(4). SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO (B)(4). DESPITE THE A9 LOT NUMBER (B)(6)2019 THE MALLET EXHIBITS HEAVY AND EXCESSIVE USAGE. THE USEFUL LIFE HAS BEEN EXCEEDED.

    Description of Event or Problem · 0

    THE REPORT STATES: I HAVE ANOTHER OF THE SAME MALLET THAT BROKE A FEW MONTHS BACK, THAT BROKE DURING A CASE TODAY. HE USES THIS ON TOTAL HIP CASES TO TRIAL AND SET CUP AND FEMORAL STEM COMPONENTS. THE PATIENT WAS NOT INJURED. THIS WAS NOT THE FIRST TIME THE MALLET WAS USED.

    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

    THE REPORT STATES: I HAVE ANOTHER OF THE SAME MALLET THAT BROKE A FEW MONTHS BACK, THAT BROKE DURING A CASE TODAY. HE USES THIS ON TOTAL HIP CASES TO TRIAL AND SET CUP AND FEMORAL STEM COMPONENTS. THE PATIENT WAS NOT INJURED. THIS WAS NOT THE FIRST TIME THE MALLET WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15643 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1