BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14242920 · Received April 28, 2022

    Report

    Report Number
    1038671-2022-00488
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    July 10, 2018
    Report Date
    April 28, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH, FEI 1038671, HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. VISUAL EVALUATION CONDITION/FINDINGS (CONDUCTED WITH A 7X OR L0X OPTICAL UNLESS OTHERWISE SPECIFIED)-THE BROKEN DEVICE APPEARS CONSISTENT WITH CRACK INITIATION, PROPAGATION, AND ULTIMATE FRACTURE OF THE DEVICE CAUSED BY A STRESS RISER INTRODUCED DURING IMPACTION. ALL OTHER ASPECTS OF THE DEVICE APPEAR UNREMARKABLE AND CONSISTENT WITH YEARS OF USE. DESIGN-RELATED ISSUES: THE DESIGN OF THE HUMERAL LINER IMPACTOR TIP HAS BEEN IN THE FIELD SINCE 2007. EXACTECH IS AWARE OF 19 SIMILAR COMPLAINT REPORTS INVOLVING 24 HUMERAL LINER IMPACTOR TIP SINCE 2008. THE FREQUENCY OF OCCURRENCE RANKING SCALE IS VERY LOW. THE DESIGN OF THIS DEVICE HAS SINCE BEEN UPDATED TO INCREASE THE THICKNESS AT THE TIP AND MODIFY THE CONNECTION FEATURES DIMENSIONS IN DCRTC- 14-0272. MFG-RELATED ISSUES: EXACTECH IS NOT AWARE OF ANY OTHER COMPLAINTS INVOLVING PARTS FROM THIS MANUFACTURING LOT, WHICH HAS BEEN IN THE FIELD SINCE 2013. THIS DEVICE WAS MANUFACTURED PRIOR TO THE DESIGN UPDATE. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING RELATED. CORRECTIVE ACTION IS NOT REQUIRED BECAUSE THE DESIGN OF THIS DEVICE HAS SINCE BEEN UPDATED, THE OCCURRENCE RATE IS " VERY LOW", AND THE RISK IS CAPTURED IN THE RMR. THE BROKEN DEVICE REPORTED WAS LIKELY THE RESULT OF A STRESS RISER INTRODUCED DURING IMPACTION, WHICH LED TO CRACK INITIATION, PROPAGATION, AND ULTIMATE FRACTURE OF THE DEVICE. THE DESIGN HAS SINCE BEEN UPDATED. IFU 700-096-181: INSTRUMENT INSPECTION VISUALLY INSPECT THE INSTRUMENTS FOR DAMAGE SUCH AS FRACTURES; CRACKS; GOUGES; DEFORMATION; BURRS; DISCOLORATION, CORROSION, OR RUST; EXCESSIVE COMPONENT WEAR; NICKS ON CUTTING SURFACES, MISSING OR LOOSE COMPONENTS; BLOCKAGES IN CANNULAE, CLEANING HOLES OR OTHER CAVITIES THAT CANNOT BE REMOVED VIA STANDARD CLEANING; WORN OR DIFFICULT TO READ MARKINGS/ENGRAVINGS; OR OTHER APPARENT DAMAGE. CHECK THE FUNCTION OF MECHANISMS BY ACTUATING ANY LEVERS, KNOBS, SWITCHES, CONNECTORS, SLIDING FEATURES, HINGES, OR OTHER MECHANICAL INTERFACE FEATURES. ENSURE SMOOTH OPERATION OF THESE FEATURES OVER THEIR FUNCTIONAL RANGE OF MOTION. IF DAMAGE, WEAR, OR NON-FUNCTIONING/POORLY FUNCTIONING MECHANISMS ARE FOUND, DO NOT USE THE INSTRUMENT, AND CONTACT THE SALES REPRESENTATIVE OR CUSTOMER SERVICE FOR DISPOSITION. IFU 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 SURGERY, AND 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 DESIGN ISSUES OR MANUFACTURING ISSUES. THERE WAS NO REPORTED PATIENT ADVERSE EVENT DUE TO THE IMPACTOR TIP FRAGMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM OUS THAT DURING AN ORTHOPEDIC SURGERY THE IMPACTING PROCESS THE TIP FRACTURED AND SEPARATED FROM THE IMPACTOR HEAD. THE SURGEON TEMPLATED FOR A 36MM GLENOSPHERE/LINER COMBINATION. WHEN IMPACTING THE 36MM HUMERAL LINER, THE CLOSEST FITTING LINER WAS THE 38MM LINER IMPACTOR TIP. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT ADVERSE EVENT OR DELAY TO SURGERY. NO PIECES FELL INTO THE SURGICAL SITE. ALL PIECES WERE RETURNED TO THE HEAD OFFICE AFTER BEING STERILIZED AND ARE BEING REPLACED. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100995 EXACTECH HUM LNR IMPACT TIP 38M LXH EXACTECH, INC. 54694024

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female