BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG., 5MM FEMORAL AIMER

    MDR report key: 6104719 · Received November 15, 2016

    Report

    Report Number
    0002936485-2016-01076
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    September 28, 2016
    Report Date
    June 5, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS (B)(4).

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: THE TIP GOT SEPARATED FROM THE GUIDE AND STAYED INSIDE THE PATIENT. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE OF TIP GOT SEPARATED WAS CONFIRMED. HOWEVER, STRYKER'S INVESTIGATION OF THE DEVICE CONFIRMED THE BROKEN PIECE WAS RECOVERED AND RETURNED WITH THE DEVICE. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE PROBABLE CAUSE COULD BE USER APPLIED EXCESSIVE FORCE TO THE DEVICE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP GOT SEPARATED FROM THE GUIDE AND STAYED INSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE TIP GOT SEPARATED FROM THE GUIDE AND STAYED INSIDE THE PATIENT. STRYKER'S INVESTIGATION OF THE DEVICE CONFIRMED THE BROKEN PIECE WAS RECOVERED AND RETURNED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753929 PKG., 5MM FEMORAL AIMER ACCESSORIES,ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE 45-08456-MD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other