BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIETER MALLEUS NIPPER UP-CUT 75MM

    MDR report key: 10976960 · Received December 9, 2020

    Report

    Report Number
    9610612-2020-00885
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Report Date
    March 9, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JYR
    PMA / PMN Number
    A921718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4-UDI, H4 - MANUFACTURE DATE. INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE WORKING ENDS OF BOTH DEVICES ARE FRACTURED.THE FOOTPLATES OF BOTH DEVICES ARE FRACTURED. THE ANALYSIS OF THE FRACTURE PATTERNS ILLUSTRATES FORCED FRACTURES DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINTS OF RUPTURES. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 3(5) PROBABILITY OF OCCURRENCE 2(5)) 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 THERE IS CAPA IS NOT 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 OG300R - DIETER MALLEUS NIPPER UP-CUT 75MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE STAMPS BREAK INTRAOPERATIVELY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00884 ((B)(4) + OG300R).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439366 DIETER MALLEUS NIPPER UP-CUT 75MM OTOLOGY JYR AESCULAP AG OG300R 4510505995

    Patients

    Seq Age Sex Outcome Treatment
    1