BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGATURE CUTTER L:125MM

    MDR report key: 15456749 · Received September 20, 2022

    Report

    Report Number
    9610612-2022-00277
    Event Type
    Injury
    Date Received
    September 20, 2022
    Report Date
    November 16, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    DZC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INVESTIGATION: THE MICROSCOPIC EXAMINATION HAS SHOWN THAT THE COMPLETE CARBIDE INSERT HAS BROKEN OUT OF THE WORKING END OF THE INSTRUMENT. BOTH BREAKAGE SURFACES SHOW CLEARLY VISIBLE SOLDER RESIDUES. IN ADDITION, THE INSTRUMENT AS WELL AS THE BROKEN-OUT CARBIDE INSERT WERE SUBJECTED TO A HARDNESS MEASUREMENT WITH THE RESULT THAT THERE ARE NO DEVIATIONS FROM THE TARGET VALUES. NO ABNORMALITIES COULD BE DETECTED IN THIS RESPECT. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) WILL BE CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS FROM THE QUALITY COORDINATOR OF THE PRODUCT PLANT. THE RESULTS OF THE REVIEW WILL BE DOCUMENTED WITHIN THE COMPLAINT; IF THE REVIEW SHOWS ANY CONSPICUITIES, THE REPORT WILL BE UPDATED AND ACTIONS WILL BE INITIATED. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL ((4)5 SEVERITY X PROBABILITY OF OCCURRENCE 1(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: DUE TO THE FACT THAT THIS INSTRUMENT WAS PRODUCED IN 2014, THE PRODUCT HAS UNDERGONE MANY APPLICATION CYCLES AS WELL AS MAINTENANCE CYCLES. WE ASSUME THAT DUE TO RECURRING HIGH LOAD SITUATIONS AND POSSIBLE OVERLOADING, THE CARBIDE INLAY FINALLY BROKE OUT ON ONE SIDE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE PROBLEM CANNOT CLEARLY BE DETERMINED. THERE IS NO INDICATION FOR A MATERIAL OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH DP511R - LIGATURE CUTTER L:125MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CUTTER BROKE OFF IN THE PATIENT'S MOUTH. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PIECE WAS REMOVED FROM THE THROAT. FURTHER DETAILS WERE NOT PROVIDED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680046 LIGATURE CUTTER L:125MM DENTAL DZC AESCULAP AG DP511R 4505883915

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention