BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YASARGIL SPRING-HK F/GALEA FIXATIONLRG

    MDR report key: 9132281 · Received September 27, 2019

    Report

    Report Number
    9610612-2019-00655
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    July 7, 2019
    Report Date
    November 22, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GDG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: WE RECEIVED A COMPLAINT ABOUT TEN FF022R. UP TO NOW, THE INSTRUMENTS ARE NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION: UP TO NOW, NO PRODUCTS AT HAND. BATCH HISTORY REVIEW: THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE NO PRODUCT AVAILABLE AND THEREFORE IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE. IT APPEARS THAT THE CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THERE IS THE POSSIBILITY THAT THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE: UNFORTUNATELY DUE TO A LACK OF DATA AND WITHOUT THE PRODUCT WE CAN NOT DETERMINE THE EXACT CAUSE. ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. THERE IS THE POSSIBILITY THAT THE FRACTURE WAS CAUSED DUE TO AN IMPROPER HANDLING OR THE FRACTURE WAS CAUSED BY A STRESS-CORROSION CRACKING. POSSIBLY AN IMPROPER HANDLING COULD LED TO A PRE-DAMAGE OR SIMILAR DUE TO PREVIOUS SURGERIES. DUE TO AN EXISTING PRE-DAMAGE OR WEAK POINT, THE REPROCESSING COULD BE FRACTURE-TRIGGERING. IF FURTHER INVESTIGATIONS ARE REQUIRED, THE PRODUCTS SHOULD BE PROVIDED FOR EXAMINATION. CORRECTIVE ACTION: ACCORDING TO SA-DE13-M-4-2-04-000-0 (CORRECTIVE ACTION & PREVENTIVE ACTION) THERE IS NO CAPA NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT THE YASARGIL SPRING-HK F/GALEA FIXATION LRG. DURING SURGERY THE INSTRUMENT RING IS FRACTURING ON THE STAINLESS. THERE WAS NO PATIENT HARM. NO ADDITIONAL INTERVENTION WAS REQUIRED ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926002 YASARGIL SPRING-HK F/GALEA FIXATIONLRG INSTRUMENTS FOR NEUROSURGERY GDG AESCULAP AG FF022R

    Patients

    Seq Age Sex Outcome Treatment
    1