BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 1657448 · Received April 9, 2010

    Report

    Report Number
    1818910-2010-01900
    Event Type
    Injury
    Date Received
    April 9, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 10, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJD
    PMA / PMN Number
    K983014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO REMOVE A 6.5MM ACETABULAR SCREW THAT WAS TOO LONG FOR THE HOLE CHOSEN IN CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX20MM 87NJD; 87LPH NJD DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA 418164

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention