BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLDER FOR REAMING GUIDES

    MDR report key: 7525111 · Received May 18, 2018

    Report

    Report Number
    1818910-2018-59899
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    April 20, 2018
    Report Date
    April 20, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    UDI-DI
    10603295116127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROX REAMING GUIDE 2307-74-012 STUCK IN HUMERUS. HOLDER 2307-74-001 WOULD NOT REMOVE GUIDE. DOCTOR DID A OSTEOTOME WHICH ALLOWED GUIDE TO BE REMOVED. AFTER OSTEOTOME, HOLDER WAS REATTACHED TO GUIDE FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368170 HOLDER FOR REAMING GUIDES EXTREMITY INSTRUMENTS : HANDLES LXH DEPUY FRANCE SAS - 3003895575 10603295116127

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR