BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CAPTURE - DISTAL RESECTION

    MDR report key: 4221738 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04142
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    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 AND RESULTS: DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS INDICATED NO EVIDENCE OF A LINE-TO-LINE OR INTERFERENCE FIT ON THE CROSS PIN OR ON THE INNER DIAMETERS OF THE TRIGGER HOLES. THE LACK OF INTERFERENCE FIT LIKELY RESULTED IN AN INSUFFICIENTLY SUPPORTED JOINT WITH THE WELD ALONE BEARING THE MAJORITY OF THE LOADS EXERTED ON THE CROSS 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 HAS BEEN A PREVIOUSLY REPORTED EVENT FOR THE SAME LOT NUMBER. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THERE WAS A SUPPLIER MANUFACTURING NONCONFORMANCE AS MATERIAL ANALYSIS IDENTIFIED THAT THERE WAS NO EVIDENCE OF A LINE-TO-LINE OR INTERFERENCE FIT ON THE CROSS PIN OR ON THE INNER DIAMETERS OF THE TRIGGER HOLES. 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 THE NURSE OF THE HOSPITAL THAT THE BOLT BECAME LOOSEN DURING A SURGERY PROCEDURE. LATCHING WAS NOT POSSIBLE ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE OF THE HOSPITAL THAT THE BOLT BECAME LOOSEN DURING A SURGERY PROCEDURE. LATCHING WAS NOT POSSIBLE ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703287 MODULAR CAPTURE - DISTAL RESECTION IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH ER7MA4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other