BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 11359312 · Received February 22, 2021

    Report

    Report Number
    1038671-2021-10043
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    April 7, 2017
    Report Date
    February 22, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020) AND A PORTION OF COMPLAINTS FROM 2013-2017. THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. THE DEVICE WAS RETURNED; HOWEVER, IT WAS UNAVAILABLE FOR ANALYSIS. DESIGN-RELATED ISSUES: THE DESIGNS OF THE LPI FIT TAMP HEAD AND THE LPI FIT TAMP GUIDE HAVE BEEN IN THE FIELD SINCE 2010. 48 COMPLAINT REPORTS INVOLVING 49 TIBIAL TAMP HEAD DUE TO MALFUNCTION OF THE MATING FEATURE (FRACTURED, DEFORMATION, NOT REPORTED) SINCE 2010. SINCE THE TAMP HEAD IS USED IN PREPARATION FOR THE TIBIAL TRAY, THE SALES DATA FOR ALL LOGIC TIBIAL FIT TRAYS WAS USED TO CALCULATE AN APPROXIMATE COMPLAINT OCCURRENCE RATE OF <.05%. THIS IS CONSIDERED "VERY LOW" ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE. THEREFORE, THIS DOES NOT APPEAR TO BE DESIGN-RELATED. MFG-RELATED ISSUES: 2 OTHER COMPLAINTS INVOLVING PARTS FROM THIS MANUFACTURING LOT OF 25 UNITS (TAMP HEAD) AND 6 OTHER COMPLAINTS INVOLVING PARTS FROM THIS MANUFACTURING LOT OF 25 UNITS (TAMP GUIDE), WHICH HAVE BOTH BEEN IN THE FIELD SINCE 2016. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE TAMP HEAD DURING A PREVIOUS COMPLAINT INVESTIGATION, AND ALL PARTS WERE ACCEPTED WITH CONFORMANCE TO THE DEVICE SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE TAMP GUIDE DURING A PREVIOUS INVESTIGATION, AND ALL PARTS WERE ACCEPTED WITH CONFORMANCE TO THE DEVICE SPECIFICATIONS. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING-RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT (RMR) AND RISK ASSESSMENT AND CONTROLS REPORT (RACR) WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESHOLD. THE DISASSEMBLY REPORTED WAS LIKELY DUE TO DEFORMATION OF THE TAMP HEAD MATING FEATURE AS A RESULT OF MISUSE THROUGH RETROGRADE IMPACTION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IFU 700-096-004 STATES: THE SURGEON SHALL BECOME THOROUGHLY FAMILIAR WITH THE TECHNIQUE OF IMPLANTATION OF THE PROSTHESES BY: APPROPRIATE READING OF THE LITERATURE, AND TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR TOTAL KNEE ARTHROPLASTY SURGERY, AND REVIEWING INFORMATION REGARDING USE OF INSTRUMENTATION. OPTETRAK OPERATIVE GUIDE STATES: THE TAMP SHOULD BE EJECTED FROM THE PROXIMAL TIBIA BY SQUEEZING THE RELEASE LEVER. IF THE TAMP GUIDE DOES NOT DISENGAGE FROM THE TIBIA WITH THE RELEASE LEVER, A MAULDIN MULTI -TOOL CAN BE USED TO DISENGAGE IT BY INSERTING THE SMALL STUD ON THE END OF THE MAULDIN MULTI-TOOL INTO THE HOLE IN THE HANDLE OF THE TAMP, THEN ROTATING THE MAULDIN MULTI-TOOL TO LOOSEN THE TIBIAL TAMP. DO NOT HIT THE TAMP IN RETROGRADE. HITTING THE TAMP IN RETROGRADE CAN RESULT IN BREAKAGE OF THE INSTRUMENT. IT IS A CLINICAL STANDARDS OF PRACTICE PROCEDURE 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 REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED EVENT IS RELATED TO ANY MANUFACTURING ISSUES OR DESIGN ISSUES, NOR DID IT LEAD TO PATIENT IMPACT. AN INVESTIGATION WAS CONDUCTED AND STATED: THE DISASSEMBLY REPORTED WAS LIKELY DUE TO DEFORMATION OF THE TAMP HEAD MATING FEATURE AS A RESULT OF MISUSE THROUGH RETROGRADE IMPACTION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC KNEE SURGERY THE SURGEON EXPERIENCED A TIBIAL TAMP GUIDE THAT WOULD NOT LOCK THE TAMP HEAD DUE TO THE TAMP HEAD BEING BROKEN. THE DEVICE MALFUNCTION OCCURRED DURING THE REMOVAL OF THE TAMP AFTER THE KEELING PROCESS. THE SALES REPRESENTATIVE WAS PRESENT AT THE SURGERY AND REPORTED NO DEVICE FRAGMENTS FELL INTO THE SURGICAL SITE. THE SURGERY CONTINUED AND WAS COMPLETED WITHOUT ADDITIONAL ISSUES. THERE WAS MINIMAL DELAY OF SURGERY AND THERE WAS NO 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
    259697 EXACTECH COMBO TRAY ADJUSTABLE TIBIAL TAMP HEAD, NET SHAPE LXH EXACTECH, INC. 73194008

    Patients

    Seq Age Sex Outcome Treatment
    1