BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 8995727 · Received September 11, 2019

    Report

    Report Number
    3011137372-2019-00292
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 20, 2019
    Report Date
    August 20, 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 (DHR) WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666. THE DEVICE HAS SUSTAINED SIGNIFICANT DEFORMATION THROUGH REPEATED IMPACTS WITHOUT BREAKING. (1) SAMPLE OF KM46666 LOT A9 WAS RECEIVED FOR EVALUATION. THE MALLET HEAD AND THE HANDLE WERE INCLUDED. THE MALLET HEAD EXHIBITS HEAVY DEFORMATION AND THE EDGES OF THE MALLET HAVE ROLLED OVER FROM REPEATED STRIKES. THE MALLET HEAD HAS SEPARATED WITH A BIFURCRATED "STEPPED" FRACTURE PLANE INDICATING EXCESSIVE FORCE FROM BOTH SIDES OF THE MALLET HEAD WHICH IS CONSISTENT WITH THE WEAR PATTERN ON THE MALLET HEAD. A MATCHING FRACTURE PLANE WAS NOTED ON THE DEVICE HANDLE. THE FRACTURE EXHIBITS A THIN GREY LINE IN THE MIDDLE WHICH WAS THE FINAL POINT OF FAILURE. NO ANOMALIES WERE NOTED IN THE GRAIN STRUCTURE OF THE STEEL TO SUGGEST A MATERIAL DEFICIENCY.

    Description of Event or Problem · 0

    THE REPORT STATES: I ORDERED 2 OF THESE ORTHO MALLETS ON (B)(6) 2019. THE REQUESTING PHYSICIAN WAS USING IT TODAY AND THE HEAD SHEARED OFF. NO COMPLICATIONS OR INJURIES FROM THIS, LUCKILY WAS IN MIDDLE OF UPSWING AND MALLET HEAD FELL TO THE FLOOR. THERE WAS NO ADVERSE EFFECTS AND PATIENT CONDITION IS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES: I ORDERED 2 OF THESE ORTHO MALLETS ON (B)(6) 2019. THE REQUESTING PHYSICIAN WAS USING IT TODAY AND THE HEAD SHEARED OFF. NO COMPLICATIONS OR INJURIES FROM THIS, LUCKILY WAS IN MIDDLE OF UPSWING AND MALLET HEAD FELL TO THE FLOOR. THERE WAS NO ADVERSE EFFECTS AND PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794575 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1