BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A/R DIST.FEM.RESECT GUIDE 8MM

    MDR report key: 3023884 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01122
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PIN THAT DID NOT GO SMOOTHLY INTO THE 0 HOLE OF AN 8MM DISTAL FEMORAL RESECTION GUIDE WAS REPORTED. THE EVENT WAS CONFIRMED. THE 8 PIN HOLES WERE EXAMINED WITH PIN GAGES. ALL HOLES WERE DIMENSIONALLY WITHIN SPECIFICATION. ALL HOLES SHOWED SIGNS OF GALLING ON THE INNER SURFACES OF THE HOLES. THE 0 HOLE WAS IDENTIFIED AS THE WORST CASE IN TERMS OF GALLING. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. IT IS BELIEVED PATIENT FACTORS DID NOT CONTRIBUTE TO THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE DEVICE WAS DIMENSIONALLY WITHIN SPECIFICATION AND NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT WAS CAUSED BY THE OBSERVED GALLING

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TKA, A PIN DID NOT ENTER SMOOTHLY IN "+0" HOLE OF AN A/R DIST FEM RESECT GUIDE 8MM .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TKA, A PIN DID NOT ENTER SMOOTHLY IN "+0" HOLE OF AN A/R DIST FEM RESECT GUIDE 8MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127191 A/R DIST.FEM.RESECT GUIDE 8MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other