BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 13937972 · Received March 29, 2022

    Report

    Report Number
    1038671-2022-10008
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 31, 2017
    Report Date
    March 17, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF AN FDA INSPECTION CONDUCTED IN (B)(6) 2020, EXACTECH, FEI 1038671, HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. THE DEVICE IN QUESTION WAS RETURNED TO EXACTECH FOR ANALYSIS. DESIGN-RELATED ISSUES: THE LPI IMPACTOR HANDLE HAS BEEN ON THE MARKET SINCE 2011. AT THE TIME OF THE ENGINEERING EVALUATION, (B)(6) 2019 EXACTECH WAS AWARE OF 35 COMPLAINTS INVOLVING THE HANDLE SINCE 2014. BECAUSE THIS DEVICE IS USED IMPLANT TIBIAL TRAYS, SALES DATA FOR TIBIAL TRAYS WAS USED TO CALCULATE AN APPROXIMATE COMPLAINT OCCURRENCE RATE OF <0.5%. 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 AWARE OF NO OTHER COMPLAINT REPORTS INVOLVING PARTS FROM THIS MANUFACTURING LOT. THE DEVICE HISTORY RECORD COULD NOT BE FOUND FOR REVIEW. THEREFORE, IT CANNOT BE DETERMINED WHETHER OR NOT THIS ISSUE IS MANUFACTURING-RELATED. RISK MANAGEMENT: A REVIEW OF THE RISK MANAGEMENT REPORT (RMR) WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESH OLD. THE RMR FOR THIS LPI IMPACTOR HANDLE, 750-2003-019- RMR-INSTRUMENTS REV-, WAS REVIEWED. THE RISK IS CAPTURED IN LINE 23. CORRECTIVE ACTION IS NOT REQUIRED BECAUSE THE OCCURRENCE RATE IS "VERY LOW", AND THE RISK IS CAPTURED IN THE RMR. MOST LIKELY CAUSE: THE MISSING SPRING FROM THE LPI IMPACTOR HANDLE REPORTED WAS LIKELY THE RESULT OF PULLING THE TIBIAL TRAY OR TIBIAL TRIALS OFF OF THE IMPACTOR HANDLE AT AN ANGLE AND/OR WITH MORE FORCE THAN NECESSARY. EXACTECH IFU 700-096-004 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 TOTAL KNEE ARTHROPLASTY 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 EXACTECH INSTRUMENTATION, DEVICES AND PROFICIENT WITH SURGICAL TECHNIQUES. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED INSTRUMENT MALFUNCTION IS RELATED TO ANY MANUFACTURING ISSUES OR DESIGN ISSUES, NOR DID IT LEAD TO ANY REPORTED PATIENT IMPACT. AN INVESTIGATION WAS CONDUCTED THAT THE MOST LIKELY ROOT CAUSE OF THE MISSING SPRING FROM THE LPI IMPACTOR HANDLE REPORTED WAS THE RESULT OF PULLING THE TIBIAL TRAY OR TIBIAL TRIALS OFF OF THE IMPACTOR HANDLE AT AN ANGLE AND/OR WITH MORE FORCE THAN NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS REPORTED THAT DURING AN ORTHOPEDIC KNEE SURGERY THE LPI IMPACT HANDLE BROKE. THE SALES REPRESENTATIVE WAS NOT PRESENT AT THE SURGERY. IT WAS REPORTED NO DEVICE FRAGMENTS FELL INTO THE SURGICAL SITE. THE SURGERY CONTINUED AND WAS COMPLETED WITHOUT ADDITIONAL ISSUES. THERE WAS NO REPORTED DELAY OF SURGERY AND THERE WAS NO REPORTED PATIENT INJURY, ADVERSE EVENT, OR CLINICAL CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2901348 EXACTECH LPI IMPACTOR HANDLE LXH EXACTECH, INC. 37471007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other