BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CAPTURE - DISTAL RESECTION

    MDR report key: 3812771 · Received May 15, 2014

    Report

    Report Number
    0002249697-2014-01857
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISASSEMBLY INVOLVING A MODULAR CAPTURE - DISTAL RESECTION WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS INDICATED AREAS OF NO WELD FUSION AT THE WELD FRACTURE SITE AND ALSO NO EVIDENCE OF LINE-TO-LINE OR INTERFERENCE FIT FOR THE MISSING PIN. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO PREVIOUSLY REPORTED SIMILAR EVENTS FOR THE SAME LOT NUMBER. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THERE WAS A SUPPLIER MANUFACTURING NONCONFORMANCE AS MATERIAL ANALYSIS IDENTIFIED THAT THERE WERE AREAS OF NO WELD FUSION AT THE WELD FRACTURE SITE AND ALSO NO EVIDENCE OF LINE-TO-LINE OR INTERFERENCE FIT FOR THE MISSING PIN. NC PR WAS ISSUED FOR THE CROSS PIN ASSEMBLED TO THE ACTION TRIGGER OF THE INSTRUMENT COMING LOOSE DURING SURGERY.

    Description of Event or Problem · 1

    IT IS REPORTED BY SURGEON OF THE HOSPITAL, THAT WHILE HE WAS PERFORMING A SURGERY PROCEDURE, HE OBSERVED THAT THE LOCKING PINS, WHICH FIXED THE BLADES, ARE GETTING LOOSEN. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY.

    Description of Event or Problem · 1

    IT IS REPORTED BY SURGEON OF THE HOSPITAL, THAT WHILE HE WAS PERFORMING A SURGERY PROCEDURE, HE OBSERVED THAT THE LOCKING PINS, WHICH FIXED THE BLADES, ARE GETTING LOOSEN. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290611 MODULAR CAPTURE - DISTAL RESECTION INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH ER6ED3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other