BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIOFIX 2 TITANIUM CLAMP 16MM

    MDR report key: 6640232 · Received June 14, 2017

    Report

    Report Number
    9610612-2017-00320
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 18, 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 THE UPPER DISK WAS STILL LOOSE AFTER FIXING AND CUTTING THE PIN. THERE WAS A 15 MINUTE DELAY IN SURGERY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT; -KEYENCE-VHX 600 D; -PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE CUTTING EDGE OF THE PIN. IT WAS CLEAR TO SEE, THAT THE PIN WAS NOT CUT CORRECTLY. THE PIN CUT SKEWED AND THROUGH THE FIXATION RIM, SO A FIXATION OF THE UPPER DISC WAS NOT POSSIBLE. 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 IFU CONTAINS CLEAR GUIDLINES FOR INSERTING THE IMPLANT AND CUTTING THE PIN. THE RISK OF COMING OFF THE PIN DURING WRONG HANDLING IS MENTIONED. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423171 CRANIOFIX 2 TITANIUM CLAMP 16MM CRANIAL IMPLANTS GXN AESCULAP AG FF491T 52269871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other