BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MB & J NO BOUNCE MALLET

    MDR report key: 1486650 · Received September 30, 2009

    Report

    Report Number
    1825034-2009-00219
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 1, 2009
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.THIS REPORT FILED SEPTEMBER 30, 2009.

    Additional Manufacturer Narrative · 1

    THE EXACT ROOT CAUSE OF THE REPORTED BREAKAGE COULD NOT BE CONFIRMED, WEAR FROM EXTENSIVE USE MAY HAVE BEEN A CONTRIBUTING FACTOR. THE DEVICE WAS MANUFACTURED IN NOVEMBER OF 1993. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE 'SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT.' THERE ARE NO IMPLICATIONS TO THE PATIENT AS RADIOGRAPHS DID NOT IDENTIFY ANY FOREIGN MATERIAL RETENTION. NO PATIENT INJURY HAS BEEN REPORTED. THE CONTENTS OF THE MALLET ARE MADE FROM STAINLESS CUT WIRE SHOT. (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY UTILIZING A MALLET IN 2009. DURING THE PROCEDURE, THE MALLET BROKE OPEN, AND THE INTERIOR CONTENTS SPILLED INTO THE PATIENT'S WOUND. THE SITE WAS CLEANED AND RADIOGRAPHS WERE TAKEN AND READ AS NEGATIVE. THE PATIENT WAS ALSO GIVEN EXTRA ANTIBIOTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY UTILIZING A MALLET ON (B) (6) 2009. DURING THE PROCEDURE, THE MALLET BROKE OPEN AND THE INTERIOR CONTENTS SPILLED INTO THE PATIENT'S WOUND. THE SITE WAS CLEANED AND RADIOGRAPHS WERE TAKEN AND READ AS NEGATIVE. THE PATIENT WAS ALSO GIVEN EXTRA ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MB & J NO BOUNCE MALLET MALLET, ORTHOPEDIC HXL BIOMET ORTHOPEDICS N/A 124080

    Patients

    Seq Age Sex Outcome Treatment
    1