BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS MODULAR DISTAL CAPTURE

    MDR report key: 3781220 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01669
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SUBCOMPONENT DISSOCIATION INVOLVING A TRIATHLON MODULAR DISTAL CAPTURE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION CONFIRMED THE EVENT. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE NO RECORDS WERE PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE REPORTED EVENT WAS CONFIRMED. A MATERIAL ANALYSIS PERFORMED FOR THE SAME PRODUCT AND ISSUE FOUND NO EVIDENCE ON THE PINS TO INDICATE PRESS-FIT CONDITIONS. EXAMINATION WITH THE MATERIAL ANALYSIS TEAM CONFIRMED THE SUBJECT TO BE WITHIN THE SCOPE OF AN NC THAT WAS RAISED WITH THE SUPPLIER TO ADDRESS THE OBSERVED NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY WHILE THE SURGEON WAS CUTTING THE DISTAL FEMUR, THE NAIL AND THE LOCKING MECHANISM FELL OUT OF THE CAPTURE SO THE CAPTURE IS NOW STUCK ON THE CUTTING BLOCK. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY WHILE THE SURGEON WAS CUTTING THE DISTAL FEMUR, THE NAIL AND THE LOCKING MECHANISM FELL OUT OF THE CAPTURE SO THE CAPTURE IS NOW STUCK ON THE CUTTING BLOCK. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260325 MIS MODULAR DISTAL CAPTURE INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH AF4C07

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other