BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE SPACER BLOCK

    MDR report key: 3072713 · Received April 23, 2013

    Report

    Report Number
    0002249697-2013-01364
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    January 15, 2013
    Report Date
    April 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED. MATERIAL ANALYSIS CONCLUDED THAT THE ADJUSTMENT WHEEL SEIZED DUE TO GALLING BETWEEN THE INNER DIAMETER OF THE WHEEL AND THE SHAFT OF THE WHEEL LOCKING NUT. DEVICE HISTORY REVIEW INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 6 OTHER EVENTS FOR THE LOT REFERENCED. THE RESULTS OF PREVIOUS INVESTIGATIONS INDICATE THAT THE DEVICE DID NOT FUNCTION PROPERLY DUE TO A LACK OF LUBRICATION. THE INVESTIGATION CONCLUDED THAT ROTARY MECHANISM JAMMING WAS CAUSED BY GALLING AS POTENTIAL ROOT CAUSE THAT CONTRIBUTES TO THE SEIZING THE TRIATHLON ADJUSTABLE SPACER BLOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO OPEN THE DEVICE. MOREOVER, IT WAS REPORTED THAT THE ROTARY MECHANISM JAMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO OPEN THE DEVICE. MOREOVER IT WAS REPORTED THAT THE ROTARY MECHANISM JAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175122 ADJUSTABLE SPACER BLOCK INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH N2019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other