BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSHING RONGEUR STR 2X10MM180MM

    MDR report key: 9286210 · Received November 6, 2019

    Report

    Report Number
    9610612-2019-00746
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Report Date
    April 14, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HTX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY . DURING INVESTIGATION THE BREAKAGE SURFACES OF THE BROKEN REMAINED PART ON THE INSTRUMENT HAS BEEN ANALYSED. THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. FURTHERMORE THE MOUTH SHOWS SEVERAL DAMAGES ON THE CUTTING EDGE AND ITS LATERAL PARTS. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS FOR THE AVAILABLE LOT NUMBER HAS BEEN REQUESTED AT THE RESPONSIBLE Q-COORDINATOR OF THE PRODUCTION PLANT. THE ANSWER IS STILL PENDING, THE 8D-REPORT WILL BE UPDATED UPON RECEIPT OF THE REVIEW-CONFIRMATION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY X PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    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 A CUSHING RONGEUR. THE JAW WAS BROKEN DURING SURGERY ON THE BONE ACCORDING TO THE REPORT. THERE WAS NO PATIENT HARM. AN ADDITIONAL MEDICAL INTERVENTION WAS NOT NECESSARY. THIS MALFUNCTION PROLONGED THE SURGERY FOR 5 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082241 CUSHING RONGEUR STR 2X10MM180MM BONE PUNCHES, RONGEURS HTX AESCULAP AG FF803R 4507865799

    Patients

    Seq Age Sex Outcome Treatment
    1