BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION REAMER ASSEMBLY OMEGA STANDARD

    MDR report key: 2090599 · Received April 19, 2011

    Report

    Report Number
    8031020-2011-00080
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON 1ST APRIL, THE SALES REP RECEIVED A CALL FROM THE CUSTOMER SAYING THE ITEMS WERE NOT CUTTING AS WELL AS THEY SHOULD. THE SALES REP ADDED THAT THE SURGEON HAS AGREED TO RE-STERILIZE THE ORIGINAL DEVICES AND USE THESE AS A BACKUP FOR THE CURRENT TRAYS. THE SALES REP FURTHER REPORTED THAT WHILST THIS ISSUE WAS NOTICED DURING SEVERAL PROCEDURES, THERE WERE NO ADVERSE CONSEQUENCES FOR ANY PTS. THE SALES REP ADDED THAT ALL THE PROCEDURES WERE COMPLETED SUCCESSFULLY WITH THE SURGEON CONTINUING TO USE THE REPORTED DEVICES, ALTHOUGH THIS DID LEAD TO A DELAY OF APPROX 5 TO 10 MINUTES IN EACH CASE. THE SALES REP WILL BE COMING BACK TO ME REGARDING DETAILS OF THE HOSPITAL'S CLEANING AND STERILIZATION PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBINATION REAMER ASSEMBLY OMEGA STANDARD INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA TBC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other