BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    26MM +0(STD) V40 TRIAL HEAD

    MDR report key: 2983653 · Received February 28, 2013

    Report

    Report Number
    0002249697-2013-00815
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT REGRADING CLEANING WAS CONFIRMED BUT THE REPORTED PRESENCE OF BACTERIA WAS NOT CONFIRMED AS NO DEVICE WERE AVAILABLE. A VISUAL INSPECTION FROM THE PROVIDED PHOTOGRAPHS OF THE REPORTED DEVICES INDICATES VISIBLE CRIMPS; O-RING IS SLIGHTLY DEFORMED, POSSIBLY DUE TO CLEANING AND/OR STERILIZATION DURING USED. DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE DEVICE WAS NOT IDENTIFIED PROPERLY. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICES WERE AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6), REPORTED VIA THE SALES REP, (B)(4), THAT STERILE SERVICES HAD SWABBED THE ORANGE O-RING FROM ONE OF THE EXETER V40 FEMORAL TRIAL HEADS AND IT HAD TESTED POSITIVE FOR BACTERIA. THE CUSTOMER REPORTED THAT THE HEADS HAVE BEEN RE-PROCESSED THROUGH AN AUTOMATED WASHER OVER 600 TIMES. THE CUSTOMER REPORTED THAT THE ORANGE O-RING THAT WAS SWABBED HAD BROKEN APART AND HAD BLACK RESIDUE ON IT. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6) REPORTED VIA THE SALES REP, (B)(6), THAT STERILE SERVICES HAD SWABBED THE ORANGE O-RING FROM ONE OF THE EXETER V40 FEMORAL TRIAL HEADS AND IT HAD TESTED POSITIVE FOR BACTERIA. THE CUSTOMER REPORTED THAT THE HEADS HAVE BEEN RE-PROCESSED THROUGH AN AUTOMATED WASHER OVER 600 TIMES. THE CUSTOMER REPORTED THAT THE ORANGE O-RING THAT WAS SWABBED HAD BROKEN APART AND HAD BLACK RESIDUE ON IT. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87686 26MM +0(STD) V40 TRIAL HEAD INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other