BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 13937973 · Received March 29, 2022

    Report

    Report Number
    1038671-2022-10009
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 23, 2017
    Report Date
    March 24, 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 DESIGN OF THIS LPI IMPACTOR HANDLE HAS BEEN IN THE FIELD SINCE 2009. AT THE TIME OF THE (B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED, AND ALL PARTS WERE ACCEPTED WITH CONFORMANCE TO PRINT SPECIFICATIONS. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE 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 DEFORMED SPRING WAS THE RESULT OF ATTEMPTING TO REMOVE THE BAL-SPRING DURING CLEANING, LEADING TO THE DEFORMATION OF THE SPRING COMPONENT. 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 AND CONCLUDED THAT THE MOST LIKELY CAUSE OF THE LPI IMPACTOR HANDLE DEFORMED SPRING WAS THE RESULT OF ATTEMPTING TO REMOVE THE BAL-SPRING DURING CLEANING, LEADING TO THE DEFORMATION OF THE SPRING COMPONENT. INFORMATION WAS NOT PROVIDED FOR: PT. INFO.

    Description of Event or Problem · 0

    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 AND CONCLUDED THAT THE MOST LIKELY CAUSE OF THE LPI IMPACTOR HANDLE DEFORMED SPRING WAS THE RESULT OF ATTEMPTING TO REMOVE THE BAL-SPRING DURING CLEANING, LEADING TO THE DEFORMATION OF THE SPRING COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2901349 EXACTECH LPI IMPACTOR HANDLE LXH EXACTECH, INC. 52176008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other