BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14490355 · Received May 24, 2022

    Report

    Report Number
    1038671-2022-10131
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    March 12, 2018
    Report Date
    May 19, 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 (B)(4), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. 5955-002 - MFG DATE: 03/30/01 34235006 - MFG DATE: 03/19/10. THE COMPLAINT PRODUCT WAS RECEIVED FOR ANALYSIS. THE REPORTED MALFUNCTION FOR BROKEN TRIAL SPINE WAS CONFIRMED. VISUAL EVALUATION CONDITION/FINDINGS (CONDUCTED WITH A 7X OR 10X OPTICAL) FRACTURED SURFACE OF THE SIZE 3 SPINE TRIAL , APPEARS CONSISTENT WITH THE SPINE TRIAL EXPERIENCING A HIGH STRESS CONCENTRATION THAT WAS LIKELY CREATED WHEN REMOVING THE SPINE TRIAL FROM THE TIBIAL INSERT TRIAL. MISSING COLOR DOT ON THE SIZE 3 SPINE TRIAL WAS LIKELY THE RESULT OF YEARS OF USE AND THE STERILIZATION AND REPROCESSING PROCEDURES PERFORMED BY THE HOSPITAL.. FRACTURED SURFACE OF THE SIZE 4 SPINE TRIAL APPEARS CONSISTENT WITH THE SPINE TRIAL EXPERIENCING A HIGH STRESS CONCENTRATION THAT WAS LIKELY CREATED WHILE REMOVING THE SPINE TRIAL FROM THE TIBIAL INSERT TRIAL. EXACTECH IS NOT AWARE OF RECEIVING ANY OTHER COMPLAINT REPORTS INVOLVING A PART FROM THE MANUFACTURING LOT 34235006 OF 50 PIECES THAT HAS BEEN IN THE FIELD SINCE 2010. EXACTECH IS NOT AWARE OF RECEIVING ANY OTHER COMPLAINT REPORTS INVOLVING A PART FROM THE MANUFACTURING LOT 5955-002 OF 35 PIECES THAT HAS BEEN IN THE FIELD SINCE 2001. THEREFORE, THIS DOES NOT APPEAR TO BE MANUFACTURING-RELATED. THE COMPLAINT REPORTED IN EXPERIENCE (B)(4) WAS LIKELY THE RESULT OF EXCESSIVE FORCES APPLIED DURING THE REMOVAL OF THE DEVICE. MATERIAL DEGRADATION FROM YEARS OF USE AND CLEANING CYCLES MAY HAVE ALSO CONTRIBUTED TO THE FAILURE MODE. 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: (1) APPROPRIATE READING OF THE LITERATURE, AND (2) TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR 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 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 ADVERSE EVENT. AN INVESTIGATION WAS CONDUCTED; THE EVENT REPORTED WAS LIKELY THE RESULT OF EXCESSIVE FORCES APPLIED DURING THE REMOVAL OF THE DEVICE. MATERIAL DEGRADATION FROM YEARS OF USE AND CLEANING CYCLES MAY HAVE ALSO CONTRIBUTED TO THE FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM AUSTRALIA THAT THERE WAS A BROKEN TRIALS SPINE. THE BROKEN INSTRUMENTS WERE FOUND WHEN THE LOANER KIT WAS RECEIVED IN THE WAREHOUSE. THE PATIENT WAS STABLE AFTER SURGERY. THERE WAS NO REPORTED ADVERSE EVENT FOR THE PATIENT. THERE WERE NO AGENTS PRESENT AT THE TIME OF SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472965 EXACTECH CC SPINE TRIAL SZ 4 LXH EXACTECH, INC. 34235006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other