BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP MBT CEM KEEL PUNCH SZ 4-7

    MDR report key: 4112718 · Received September 24, 2014

    Report

    Report Number
    1818910-2014-28726
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE REPORTED BREAKAGE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE FRACTURE; HOWEVER, HEAVY USAGE OVER TIME AND OR USER ERROR/MISUSE COULD BE CONTRIBUTING FACTORS. (B)(4) HAS BEEN INITIATED TO INVESTIGATE, IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE TOP NOTCH HAS BROKEN OFF OF THE CEMENT PUNCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596116 HP MBT CEM KEEL PUNCH SZ 4-7 KNEE INSTRUMENT/TRIAL LXH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC J0909

    Patients

    Seq Age Sex Outcome Treatment
    1