BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE ELEVATOR 17MM WI.240MM

    MDR report key: 6181913 · Received December 16, 2016

    Report

    Report Number
    2916714-2016-01054
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    September 20, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GEG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY. DURING A KNEE SURGERY THE BONE ELEVATOR DEVICE BROKE.

    Additional Manufacturer Narrative · 1

    THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE FRACTURE SURFACE OF THE INSTRUMENT. HERE WE FOUND GAPS. ADDITIONALLY WE MADE A INSPECTION OF THE FRACTURE SURFACE OF THE BROKEN FRAGMENT. HERE WE FOUND THE SAME GAPS. THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY A MATERIAL DEFECT. THE FRACTURE SURFACE EXHIBITS SIGNS OF A MATERIAL DEFECT BY COLD ROLLING. WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES WE ASSUME A HIGH STRESS. THE BREAKAGE WAS PROBABLY CONTRIBUTED TO BY THE MATERIAL DEFECT. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833428 BONE ELEVATOR 17MM WI.240MM GENERAL SURGICAL INSTRUMENTS GEG AESCULAP AG FK171R 4507729243

    Patients

    Seq Age Sex Outcome Treatment
    1 Other