BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-CHANGE ACET IMPACTOR 42MM

    MDR report key: 1112506 · Received August 7, 2008

    Report

    Report Number
    9610669-2008-00019
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 16, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN
    Product Code
    HWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTOR BROKE DURING USE. IT IS FURTHER REPORTED THAT THE HOSPITAL USED ANOTHER IMPACTOR TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-CHANGE ACET IMPACTOR 42MM INSTRUMENT HWA STRYKER ORTHOPAEDICS CAEN NA G1814989

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other