BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 12952162 · Received December 7, 2021

    Report

    Report Number
    1038671-2021-00674
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    June 6, 2019
    Report Date
    December 7, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. ENGINEERING EVALUATION COMPLETED ON 7 JAN 2020 BY (B)(4). THE DESIGN OF THE ERGO INSTRUMENTATION HAS BEEN IN THE FIELD SINCE MAY 2019. EXACTECH IS NOT AWARE OF ANY SIMILAR COMPLAINT REPORTS INVOLVING THIS DEVICE SINCE MAY 2019. BECAUSE THIS BUTTERFLY REAMER IS USED IN ANATOMIC TOTAL SHOULDER SURGERIES, THE TOTAL NUMBER OF ESTIMATED CASES PERFORMED UTILIZING ANATOMIC ERGO INSTRUMENTATION SINCE ITS LAUNCH WAS USED TO CALCULATE AN APPROXIMATE COMPLAINT OCCURRENCE RATE OF <(B)(4). THIS IS CONSIDERED ¿VERY LOW¿ ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE DESIGN RELATED. MFG-RELATED ISSUES: EXACTECH IS NOT AWARE OF ANY OTHER COMPLAINTS INVOLVING PARTS FROM THIS MANUFACTURING LOT OF 52 UNITS. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT (RMR) WAS NOT CONDUCTED AS THE REPORTED FAILURE COULD NOT BE RECREATED OF CONFIRMED. CORRECTIVE ACTIONS ARE NOT REQUIRED BECAUSE THE OCCURRENCE RATE IS ¿VERY LOW.¿ THE MOST LIKELY UNDERLYING CAUSE FOR THE BUTTERFLY REAMER PITCH DISCREPANCY REPORTED IN (B)(4) MAY BE RELATED TO THE WAY THE DEVICE WAS USED BUT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE FAILURE COULD NOT BE RECREATED OR CONFIRMED. 12-0001666 REV. A 0421 -REAMING OPTIONS THE EQUINOXE REVERSE SYSTEM PROVIDES TWO OPTIONS TO REAM THE GLENOID: 1) PILOT TIP AND 2) CANNULATED. THE CANNULATED REAMERS ROTATE A 3.2MM K-WIRE AND PROVIDE THE SURGEON MAXIMUM PRECISION. ENSURE THAT THE GLENOID IS REAMED UP TO THE APPROPRIATE SIZE GLENOSPHERE. NOTE: AVOID APPLYING A BENDING FORCE TO THE PILOT TIP REAMER DRIVER OR USING THE DRIVER TO RETRACT THE HUMERAL HEAD AS THIS MAY CAUSE FRACTURE OF THE 3.2MM K-WIRE OR PILOT TIP. NOTE: TWO HANDLE ORIENTATIONS (DELTOPECTORAL OR SUPEROLATERAL APPROACH) ARE OFFERED FOR THE TWO DIFFERENT SURGICAL APPROACHES. NOTE: SEE ¿PREPARING THE GLENOID¿ IN THE EQUINOXE PLATFORM SHOULDER SYSTEM WITH ERGO INSTRUMENTS OPERATIVE TECHNIQUE 1 FOR TIPS ON RETRACTOR POSITIONING. 00-0000121 REV. B. PLATFORM SHOULDER SYSTEM WITH ERGO INSTRUMENTS OPERATIVE TECHNIQUE; 718-01-30 REV. J, PLATFORM SHOULDER SYSTEM OPERATIVE TECHNIQUE; 718-04-45 REV. C IFU STATES: THE SURGEON SHALL BECOME THOROUGHLY FAMILIAR WITH THE TECHNIQUE OF IMPLANTATION OF THE PROSTHESES BY: (1) APPROPRIATE READING OF THE LITERATURE, AND (2) TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR SURGERY, AND (3) REVIEWING INFORMATION REGARDING USE OF INSTRUMENTATION. IT IS A CLINICAL STANDARD OF PRACTICE IN THE OPERATING ROOM THAT ALL INSTRUMENTS SHOULD BE VISUALLY AND FUNCTIONALLY INSPECTED BEFORE USE, THESE GUIDELINES ARE FROM STANDARD ASSOCIATION OF PERI-OPERATIVE REGISTERED NURSES (AORN) GUIDELINES. SURGEONS ARE TO BE FAMILIAR AND KNOWLEDGEABLE WITH ALL INSTRUMENTATION, DEVICES AND PROFICIENT WITH SURGICAL TECHNIQUES. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED EVENT IS RELATED TO ANY MANUFACTURING ISSUES OR DESIGN ISSUES. THE DIFFERENT CUTTING PATTERN CAUSED THE SURGEON TO REMOVE MORE BONE CIRCUMFERENTIALLY, THE SURGEON SWITCHED TO OLD REAMERS TO MAKE CONCENTRIC SURFACE TO CONTINUE THE SURGERY. AN INVESTIGATION WAS CONDUCTED; THE MOST LIKELY UNDERLYING CAUSE FOR THE BUTTERFLY REAMER PITCH DISCREPANCY REPORTED MAY BE RELATED TO THE WAY THE DEVICE WAS USED BUT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE FAILURE COULD NOT BE RECREATED OR CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE US THAT DURING AN ORTHOPEDIC SURGICAL PROCEDURE THE SURGEON EXPERIENCED AN ISSUE WITH A REAMER. WHEN REAMING THE GLENOID, THE TEETH OF THE REAMER CUT AT TWO DIFFERENT DEPTHS. THE SURGEON SWITCHED TO THE ¿OLD¿ ANATOMIC REAMERS TO CREATE SYMMETRICAL SURFACE BEFORE IMPLANTING THE GLENOID. THE AGENT STATED THAT THE SURGEON WAS REAMING ON AXIS, BUT THE DIFFERENT DEPTH CREATED ON THE GLENOID FACE FROM TEETH OF THE REAMER, CAUSED THE SURGEON TO REMOVE MORE BONE CIRCUMFERENTIALLY, HE THEN SWITCHED TO OLD REAMERS TO MAKE CONCENTRIC SURFACE TO CONTINUE THE SURGERY. THERE WAS A 2-MINUTE DELAY TO SURGERY, BUT THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REP WAS PRESENT AT THE TIME OF SURGERY. THE DEVICE WAS RETURNED IN AN ERGO KIT AND WAS UNABLE TO BE LOCATED FOR ANALYSIS. THE LOT NUMBER IS NOT REPORTED. NO PATIENT INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844351 EXACTECH MOD ATSA REAMER MEDIUM BUTTERFLY LXH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention