BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCCONNELL UEP 7-200 ACCESSORY

    MDR report key: 2026767 · Received March 12, 2011

    Report

    Report Number
    1641643-2011-00001
    Event Type
    Other
    Date Received
    March 12, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MCCONNELL ORTHOPEDIC MFG. CO.
    Product Code
    FWZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOT NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    THE PT AT THE SURGICAL SPECIALTY CTR WAS BEING PREPARED FOR SURGERY WHEN IT WAS DISCOVERED THAT THE UEP (7-200) SUPPORT ACCESSORY MECHANISM DID NOT FUNCTION PROPERLY, I.E. THE BALL SCREW (KNURL KNOB) CROSS- THREADED BECAUSE OF IMPROPER USE BY SOMEONE AT THE HOSP AND THE PHYSICIAN WAS UNABLE TO ADJUST SAME. ANOTHER UEP 7-200 UEP HAD TO BE LOCATED BY THE TECHNICIAN TO CONTINUE WITH THE PREPARATION OF THE PT FOR SURGERY. CONSEQUENTLY, THE PT HAD TO BE PUT UNDER ANESTHESIA FOR AN ADD'L PERIOD OF TIME (POSSIBLY COMPROMISING THE PATIENT'S HEALTH - SO THAT THE BACKUP UEP 7-200 COULD BE PROPERLY PREPARED). ACCORDING TO THE ORTHOPEDIC TEAM LEADER THE PT WAS NOT HARMED AND THERE WAS NO RE-OPERATION NECESSARY. THE UEP 7-200 WAS RENDERED NON-FUNCTIONAL AND SENT BACK TO MCCONNELL ORTHOPEDIC MFG UNDER THE AUSPICES OF A SVC ISSUE. COMPLAINT (B)(4) WAS SUMMARILY FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCCONNELL UEP 7-200 ACCESSORY UEP 7-200 FWZ MCCONNELL ORTHOPEDIC MFG. CO. 7-200 051210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK