BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE ELEVATOR 10MM WI.220MM

    MDR report key: 16701954 · Received April 7, 2023

    Report

    Report Number
    9610612-2023-00070
    Event Type
    Injury
    Date Received
    April 7, 2023
    Report Date
    May 1, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    GEG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/ CORRECTION: B5 - LEADING MATERIAL CODE AND NAME UPDATED. D1 - BRAND NAME UPDATED. D4 - MODEL AND CATALOG NUMBER UPDATED, LOT ADDED. D9 - PRODUCT RETURNED DATE. H3 - DEVICE EVALUATION. H6 - CODES UPDATED. INVESTIGATION RESULTS: VISUAL INVESTIGATION: A BONE LIFTER WITH CLEAR SIGNS OF USE AND DAMAGED WORKING END WAS PROVIDED TO US FOR EXAMINATION.DURING THE OPTICAL EXAMINATION WE COULD SEE DAMAGE ON THE ENTIRE SURFACE IN THE FORM OF SCRATCHES, PRESSURE AND/OR IMPACT POINTS WHICH WERE ACCOMPANIED BY A DISPLACEMENT OF THE MATERIAL TO THE SIDE AT THE TIP. THE HARDNESS TEST RESULTED IN A VALUE OF 481.1 HV5. 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 2(5) X PROBABILITY 2(5) OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: THE DAMAGE INDICATES THAT THE INSTRUMENT HAS COME INTO CONTACT WITH HARD MATERIAL (BONE PLATE, NAILS, SCREWS...) DURING USE.THE PRESSURE MARK AT THE WORKING END WAS CAUSED BY AN OVERLOAD SITUATION. NO MATERIAL WAS REMOVED BUT ONLY DISPLACED - WHICH ALSO EXPLAINS THE BULGES TO THE SIDE. WITH A SPECIFICATION OF 420 +110 HV5, THE MEASURED VALUE IS THUS WITHIN THE TARGET RANGE. USER ERROR IS SUSPECTED, BUT THIS CANNOT BE PROVEN. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    UPDATE: LEADING MATERIAL CODE CHANGED TO FK170R AND NAME CHANGED TO BONE ELEVATOR 10MM WI.220MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FK171R - BONE ELEVATOR 17MM WI.240MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE OPERATION TECHNICIAN FOUND THE INSTRUMENT TIP WAS CHIPPED DURING RIGHT HEMIARTHROPLASTY SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415625 BONE ELEVATOR 10MM WI.220MM GENERAL SURGICAL INSTRUMENTS GEG AESCULAP AG FK170R 4513161382

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention