BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIOFIX 2 APPLYING FORCEPS NON-DETACH

    MDR report key: 7478099 · Received May 1, 2018

    Report

    Report Number
    9610612-2018-00210
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    March 23, 2018
    Report Date
    June 11, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    GXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018 . MANUFACTURING SITE EVALUATION: THREE PRODUCTS DID NOT WORK PROPERLY. THEREFORE, ALL OF THE DISKS WERE REMOVED. THREE UPPER AND THREE LOWER DISCS ARRIVED IN COMMON WITH THREE PINS. TWO OF THE UPPER DISCS WERE BENT. A VISUAL INSPECTION OF THE LOWER DISCS, ESPECIALLY THE PINS AND THEIR CUTTING EDGES. IT APPEARS A PIN WHICH WAS CUT SKEWED AND UNDERNEATH THE LAST RIM, SO THE DISC CAME OFF. THE PIN OF THE DISC WAS CUT SKEWED TOO AD THE DAMAGES OF THE RIMS AT ONE SIDE ARE A HINT FOR A NOT CORRECT PUSHED DOWN UPPER DISC. IT IS ASSUMED DURING REMOVAL THE DISC, IT CAME TO THE DEFORMATION. THE PIN OF THE DISC WAS CUT SKEWED THROUGH A FIXATION RIM, SO THE UPPER DISC CAME OUT WITHOUT DAMAGES. THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THE ROOT CAUSE FOR THE PROBLEM IS MOST PROBABLY USAGE RELATED. A MATERIAL DEFECT OR A MANUFACTURING ERROR CAN BE EXCLUDED. A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: PANASONIC DMC TZ8 DIGITAL CAMERA. FIRST WE MADE A VISUAL INSPECTION OF BOTH INSTRUMENTS. EXCEPT SOME SCRATCHES AND SMALL DENTS, WE FOUND NO ABNORMALITIES. THE MECHANISM OF BOTH INSTRUMENTS IS RUNNING SMOOTHLY WITHOUT ANY TICKING OR JAMMING. OUR TECHNICAL SERVICES DEPARTMENT THEN INVESTIGATED THE DEVICE AND CONCLUDED THAT THE FUNCTION AND PARAMETERS ARE ALL WITHIN SPECIFICATION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: THE INSTRUMENTS SHOWS NO SIGNS OF JAMMING, STICKING OR OTHER MALFUNCTION. THE CHECK IN THE TECHNICAL SERVICE DEPARTMENT EXHIBITS NO FUNCTIONAL DEVIATIONS. NO CAPA IS NECESSARY.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). THREE OF PRODUCTS DID NOT WORK PROPERLY. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00189, 9610612-2018-00190, 9610612-2018-00191.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320923 CRANIOFIX 2 APPLYING FORCEPS NON-DETACH CRANIOFIX 2 IMPLANTS GXN AESCULAP AG FF494R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other