BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER CUP INTRODUCER 28 MM

    MDR report key: 102735 · Received June 30, 1997

    Report

    Report Number
    57386-1997-00018
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Report Date
    June 27, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HXO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SCREW OF THE CUP INTRODUCER WOULD NOT THE HANDLE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; THEREFORE, THERE WAS NO ADVERSE CONSEQUENCE FOR ANY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER CUP INTRODUCER 28 MM INSTRUMENT HXO HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other