BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIOFIX 2 TITANIUM CLAMP 20MM

    MDR report key: 6387169 · Received March 8, 2017

    Report

    Report Number
    9610612-2017-00132
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    January 6, 2017
    Report Date
    July 17, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GXN
    PMA / PMN Number
    K972332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT WHEN USING THE PIN CUTTER UPPER DISK WAS LOOSE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT; KEYENCE-VHX 600 D MICROSCOPE; (B)(4) DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE PIN IN THE LOWER DISC. HERE WE FOUND A SLIGHTLY SKEWED CUTTING EDGE WITH A DAMAGED UPPERMOST FIXATION RIM. NEXT WE INVESTIGATED THE UPPER DISC. THE DISC IS COMPLETELY BENT FROM INSIDE TO THE OUTSIDE. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USER RELATED. RATIONAL: THE PIN WAS SKEW CUT. ONE OF THE SPRING SEGMENTS COULDN'T GET FIXED, THE DISC SEEMS LOOSE. THE SURGEON TRIED TO TAKE DOWN THE DISC, CAUSING THE DISC TO BEND (THE OTHER SPRING SEGMENTS STUCK AT THE FIXATION RIM). THE IFU CONTAINS CLEAR GUIDELINES FOR INSERTING THE IMPLANT AND CUTTING THE PIN. THE RISK OF COMING OFF THE PIN DURING INCORRECT HANDLING IS MENTIONED. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172253 CRANIOFIX 2 TITANIUM CLAMP 20MM CRANIAL IMPLANTS GXN AESCULAP AG FF492T 52268829

    Patients

    Seq Age Sex Outcome Treatment
    1 Other