BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIETER MALLEUS NIPPER UP-CUT 75MM

    MDR report key: 13792837 · Received March 17, 2022

    Report

    Report Number
    9610612-2022-00071
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    February 9, 2022
    Report Date
    May 31, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    JYR
    UDI-DI
    04038653051588
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INVESTIGATION: THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. NO PORES, INCLUDSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. THE BREAKAGE DUE TO OVERLOAD WAS PROBABLY FAVOURED BY A GRADATION THAT WAS MILLED TOO DEEP. THE AGE OF THIS BATCH INDICATES THE OLD PRODUCTION STATUS. WE THEREFORE ASSUME THAT THIS IS THE SAME DEFECT. HERE IT WAS FOUND THAT THE DEPTH OF THE MILLED STEP WAS NOT ALWAYS MILLED ACCORDING TO SPECIFICATIONS AND THUS FAVOURED BREAKAGE. THIS IS DOCUMENTED IN A Q-NOTIFICATION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 3(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE IS MOST PROBABLY MANUFACTURING-RELATED. A PRODUCT SAFETY CASE (PSC) WILL BE INITIATED. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP AG THAT A DIETER MALLEUS NIPPER UP-CUT 75MM (PART # OG300R) WAS USED DURING A CHOLEOSTEATOME REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INSTRUMENT BROKE. REPORTEDLY, THE SURGEON NOTICED A PIECE OF METAL IN THE EAR. AFTER RETRIEVAL, THE FRAGMENT WAS DETERMINED TO BE FROM THE OG300R DEVICE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. . AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. NO ADVERSE PATIENT OUTCOME WAS REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938333 DIETER MALLEUS NIPPER UP-CUT 75MM GENERAL SURGICAL INSTRUMENTS JYR AESCULAP AG OG300R 4511920715 04038653051588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention