BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METHA PROFILER HANDLE LEFT NAVIGATED

    MDR report key: 8511626 · Received April 12, 2019

    Report

    Report Number
    9610612-2019-00268
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 12, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE RASP HANDLE. DURING AN UNSPECIFIED PROCEDURE, THE RASP HANDLE "BROKE" AND A FEW PARTS FELL INTO THE SURGICAL AREA. THE HANDLE WAS BEING HAMMERED UPON WHEN THIS OCCURRED. ALL PIECES WERE SUCCESSFULLY RETRIEVED AND REMOVED; THIS WAS CONFIRMED VIA X-RAY. REVIEW OF A PICTURE CLARIFIED THAT THE PRODUCT FELL APART AND WAS NOT BROKEN; THE LOCKING SCREW COMPONENT HAD LOOSENED AND COME APART FROM THE HANDLE. FURTHER INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304149 METHA PROFILER HANDLE LEFT NAVIGATED INSTR./MISCELL. FOR HIP ENDOPR LXH AESCULAP AG NF141R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HAMMER