BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP MBT CEM KEEL PUNCH SZ 4-7

    MDR report key: 4089948 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-27952
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CPAP (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

    SMALL TAB ON THE MBT CEMENTED PUNCH BROKE OFF DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569510 HP MBT CEM KEEL PUNCH SZ 4-7 KNEE INSTRUMENT/TRIAL LXH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC J0309

    Patients

    Seq Age Sex Outcome Treatment
    1