BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY OFFSET ACCOLADE STEM INSERTER PER FILE H1551

    MDR report key: 3603394 · Received February 3, 2014

    Report

    Report Number
    0002249697-2014-00248
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING OFF LABEL USE INVOLVING A SPECIALTY OFFSET ACCOLADE STEM INSERTER WAS REPORTED. CONCLUSION: IT WAS REPORTED THAT WHILE IMPACTING AN ACCOLADE HFX STEM WITH THE SPECIALTY ACCOLADE OFFSET STEM INSERTER THE INSTRUMENT BECAME LODGED AND STUCK IN THE STEM. A REVIEW OF THE SURGICAL PROTOCOL FOR THE ACCOLADE SYSTEM AND A REVIEW OF THE SURGEON APPROVAL LETTER FOR THE SPECIALTY ACCOLADE OFFSET STEM INSERTER INDICATED THIS INSTRUMENT IS NOT TO BE USED WITH THE ACCOLADE HFX STEM; THEREFORE, THIS APPLICATION OF THE DEVICE IS OFF LABEL USE.

    Description of Event or Problem · 1

    WHILE IMPACTING AN ACCOLADE HFX STEM, A CUSTOM BROACH HANDLE WAS USED AND BECAME LODGED AND STUCK IN THE STEM DURING IMPACTION. WE OPENED ANOTHER STEM AND USED A THREAD IN IMPACTOR WITHOUT ANY FURTHER ISSUES.

    Description of Event or Problem · 1

    WHILE IMPACTING AN ACCOLADE HFX STEM, A CUSTOM BROACH HANDLE WAS USED AND BECAME LODGED AND STUCK IN THE THE STEM DURING IMPACTION. WE OPENED ANOTHER STEM AND USED A THREAD IN IMPACTOR WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70048 SPECIALTY OFFSET ACCOLADE STEM INSERTER PER FILE H1551 INSTRUMENT MAY STRYKER ORTHOPAEDICS-MAHWAH F5C9994

    Patients

    Seq Age Sex Outcome Treatment
    1 Other