BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIETER MALLEUS NIPPER UP-CUT 75MM

    MDR report key: 12454230 · Received September 10, 2021

    Report

    Report Number
    9610612-2021-00600
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 2, 2021
    Report Date
    December 17, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JYR
    UDI-DI
    04038653051588
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. 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. 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 IT IS ALMOST CERTAIN THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE, PROBABLY DUE TO HEAVY LOADING DURING APPLICATION. BASED UPON THE INVESTIGATIONS RESULTS A 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 PART OF THE TIP HAS BROKEN OFF WHEN CUTTING A PIECE OF BONE. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351692 DIETER MALLEUS NIPPER UP-CUT 75MM ENT JYR AESCULAP AG OG300R 4511840961 04038653051588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown