BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-M 1.6MM BEADED CABLE SET VIT

    MDR report key: 3103264 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01601
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDQ
    PMA / PMN Number
    K953818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE RETURNED CABLE AND SLEEVE ARE IN PRISTINE CONDITION. VISUAL INSPECTION FOUND NO DISCREPANCIES. FUNCTIONAL INSPECTION FOUND THE CABLE CAN BE FULLY PASSED THROUGH BOTH HOLES OF THE SLEEVE WITH NO ISSUE. INSUFFICIENT MEDICAL RECORDS INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICIAN CONSULTANT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE PASSED THE FUNCTIONAL INSPECTION. FURTHER INFORMATION SUCH AS RETURN OF TENSIONER DEVICE, OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. THE REPORTED EVENT REGARDING ASSEMBLY ISSUE INVOLVING A DALL MILE CABLE SET WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE COULD NOT BE INSERTED INTO THE SINGLE SIDE TENSIONER. SO, THE SURGEON USED SPARE CABLE INTO THE SAME SINGLE SIDE TENSIONER,AND IT COULD BE INSERTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE COULD NOT BE INSERTED INTO THE SINGLE SIDE TENSIONER. SO, THE SURGEON USED SPARE CABLE INTO THE SAME SINGLE SIDE TENSIONER, AND IT COULD BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203390 D-M 1.6MM BEADED CABLE SET VIT IMPLANT JDQ STRYKER ORTHOPAEDICS-MAHWAH 41046502

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other