BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 13937975 · Received March 29, 2022

    Report

    Report Number
    1038671-2022-10004
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    April 20, 2017
    Report Date
    March 16, 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 JAN 2020, EXACTECH, (B)(4), 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. (B)(4). THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE DESIGN RELATED. MFG-RELATED ISSUES: EXACTECH IS AWARE OF 3 OTHER COMPLAINT REPORTS INVOLVING PARTS FROM THIS MANUFACTURING LOT OF (B)(4) UNITS AND THE RESULTS FROM THE INSPECTION OF ONE OF THOSE 3 DEVICES SHOWED THAT DRAWING ZONES 213-365-01 A-3 AND 213-365-01 A-2 WERE OUTSIDE SPECIFICATIONS. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE NAMED DEVICES WERE ACCEPTED WITH CONFORMANCE TO THE DEVICE REQUIREMENTS. 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 LINES 18 AND 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 BROKEN LPI IMPACTOR HANDLE REPORTED IN EXPERIENCE (B)(4) WAS LIKELY THE RESULT OF DEFORMATION FROM MULTIPLE IMPACTIONS OVER THE COURSE OF OVER 6 YEARS OF USE. 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 DISASSEMBLY REPORTED IN THIS EVENT WAS LIKELY THE RESULT OF DEFORMATION FROM MULTIPLE IMPACTIONS OVER THE COURSE OF OVER 6 YEARS OF USE. INFORMATION WAS NOT PROVIDED FOR: PT. INFO.

    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
    2902472 EXACTECH LPI IMPACTOR HANDLE LXH EXACTECH, INC. 36816002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other