BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIETER MALLEUS NIPPER UP-CUT 75MM

    MDR report key: 6407542 · Received March 15, 2017

    Report

    Report Number
    9610612-2017-00092
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 3, 2017
    Report Date
    December 5, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    JYR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: UNITED KINGDOM. IT WAS REPORTED THAT ONE OF THE INSTRUMENTS (DIETER MALLEUS NIPPE) BROKE. IT WAS REPLACED WHICH CAUSE A 20-30 MINUTE DELAY IN SURGERY. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INVESTIGATION WAS PERFORMED USING A KEYENCE VHX-5000 DIGITAL MICROSCOPE. 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 ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH/THESE BATCHES. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONAL: THIS KIND OF INSTRUMENT IS DESIGNED FOR DELICATE USE ONLY. IT IS LIABLE THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE. THE VISUAL INVESTIGATION INDICATED THAT THE QUALITY REQUIREMENTS ARE IN THE SPECIFIED TOLERANCE RANGE. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188063 DIETER MALLEUS NIPPER UP-CUT 75MM GENERAL SURGICAL INSTRUMENTS JYR AESCULAP AG OG300R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other