BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPHP MODULAR BOX CHISEL

    MDR report key: 1951223 · Received December 13, 2010

    Report

    Report Number
    2249697-2010-01720
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: A DESIGN NON-CONFORMANCE WAS OBSERVED BASED ON THE RESULTS OF THE VISUAL INSPECTION IN WHICH THE CUTTING EDGES OF THE CHISEL HAVE BECOME DEFORMED DURING USE. THE OBSERVED FAILURE RATE OF THIS DEVICE EXCEEDED THE ANTICIPATED FAILURE RATE. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CATALOG #: 1601-1210, LOT ID: B5AEC, MANUFACTURER DATE: (B)(4) 2010. CATALOG #: 1601-1210, LOT ID: B2WAE, MANUFACTURE DATE: (B)(4) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DURING A ROUTINE WAREHOUSE INSTRUMENT INSPECTION WE REALIZED THREE OF OUR REJUVENATE SETS HAD DAMAGED OSTEOTOMES. WE REPLACED THEM WITH NEW ONES AND WOULD LIKE TO HAVE THESE LOOKED AT. ESSENTIALLY THE CUTTING ASPECTS OF THESE OSTEOTOMES HAVE BEEN FOLDED BACK INTO ITSELF. WE DON'T KNOW HOW THIS HAPPENED OR WHERE, WE JUST KNOW THAT THEY WILL NOT WORK AS THEY ARE DESIGNED TO. WE PREVIOUSLY SENT IN TWO OSTEOTOMES THAT HAD THE SAME ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPHP MODULAR BOX CHISEL INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA B2WAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention