BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIOFIX 2 APPLYING FORCEPS NON-DETACH

    MDR report key: 8392169 · Received March 5, 2019

    Report

    Report Number
    9610612-2019-00161
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 19, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GXN
    PMA / PMN Number
    K972332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: KEYENCE VHX-5000 DIGITAL MICROSCOPE. PANASONIC DMC TZ8 DIGITAL CAMERA. MECMESIN AFG 500N FORCE MEASURING DEVICE. FOR INVESTIGATION WE SENT THE INSTRUMENT TO OUR TECHNICAL SERVICE DEPARTMENT. THERE THEY TESTED THE CLAMPING FUNCTION AND THE PULLING FORCE OF THE DEVICE. THE CLAMPING FUNCTION WORKED WELL. ALL MEASURED VALUES ARE WITHIN THE SPECIFICATION BETWEEN 280 NEWTONS AND 350 NEWTONS. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE: WE TESTED THE FUNCTION AND THE FORCE VALUES OF THE INSTRUMENT AND FOUND IT ACCORDING TO THE SPECIFICATION. WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES, WE ASSUME A HANDLING ERROR (NOT CORRECTLY ATTACHED TO THE PIN) OR A BENT/DEFECTIVE PIN. NO CAPA IS NECESSARY.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "THE SURGEON REPORTS THAT THE CLOSING SYSTEM APPLICATOR CLAMP ATTACHMENT IN PLACING THE CRANEOFIX IMPLANT DOES NOT MAKE THE CORRECT TIGHTENING, LEAVING THE IMPLANT WITHOUT SUFFICIENT FORCE." THERE WAS A 15 MINUTE DELAY IN SURGERY WHEN PLACING THE THIRD IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184380 CRANIOFIX 2 APPLYING FORCEPS NON-DETACH CRANIAL IMPLANTS GXN AESCULAP AG FF494R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other