BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 13929218 · Received March 28, 2022

    Report

    Report Number
    1038671-2022-00291
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    December 20, 2019
    Report Date
    March 28, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. DEVICE(S) NOT AVAILABLE FOR EVALUATION. HOSPITAL-SPECIFIC REPROCESSING INFORMATION WAS REQUESTED FROM THE SALES REPRESENTATIVE; HOWEVER, HE WAS UNABLE TO OBTAIN DETAILS REGARDING DETERGENTS, TEMPERATURE, AND TIME. THEREFORE, CONFIRMATION OF ADHERENCE TO IFU 700-096-124 REV D, REPROCESSING INSTRUCTIONS FOR REUSABLE SURGICAL INSTRUMENTATION, COULD NOT BE CONFIRMED. DESIGN-RELATED ISSUES: AS OF 6/24/2020, EXACTECH IS NOT AWARE OF ANY PREVIOUS COMPLAINT REPORTS ON THIS SPECIAL INSTRUMENT; HOWEVER, THERE ARE 57 TOTAL COMPLAINTS INVOLVING FRACTURED IMPACTOR TIPS FOR STANDARD SHOULDER INSTRUMENTATION SINCE 2011. EXACTECH IS AWARE OF 11 TOTAL COMPLAINTS INVOLVING A FRACTURED RADEL® SPHERE ON THE STANDARD INSTRUMENTATION FOR INSERTING THE HUMERAL STEM, THE PRIMARY STEM INSERTER/EXTRACTOR (CN: 301-07-10). SINCE IMPACTOR TIPS AND THE PRIMARY STEM INSERTER/EXTRACTOR ARE USED DURING BOTH ANATOMIC AND REVERSE SHOULDER ARTHROPLASTY SURGERIES, SALES DATA FOR ALL HUMERAL STEMS WAS USED TO CALCULATE AN APPROXIMATE COMPLAINT OCCURRENCE RATE OF <0.5%. THIS IS CONSIDERED ¿VERY LOW¿ ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE DESIGN RELATED. MFG-RELATED ISSUES: A TOTAL OF 29 SPECIAL BARNARD IMPACTOR TIPS WERE PRODUCED IN THREE SEPARATE LOTS (9 IN 2011 UNDER TM-2011-060, 10 IN 2012 UNDER TM-2012-521, AND 10 IN 2017 UNDER TM-2017-0131 AND DSR217046). THIS COMPLAINT INVOLVES MULTIPLE PARTS, HOWEVER, THE RELATIONSHIP TO A SPECIFIC MANUFACTURING LOT HAS NOT BEEN ESTABLISHED AS THE DSR/LOT INFORMATION WAS NOT PROVIDED. THEREFORE, THE CONTRIBUTION OF MANUFACTURING RELATED ISSUES TO THE REPORTED FAILURE CANNOT BE ASSESSED. CORRECTIVE ACTIONS ARE NOT REQUIRED BECAUSE THE OCCURRENCE RATE IS ¿VERY LOW¿, AND THE RISK IS CAPTURED IN THE TECHNICAL MEMOS. THE MOST LIKELY UNDERLYING CAUSE FOR THE FRACTURED SPECIAL QUICK IMPACTOR REPORTED IS A STRESS-RISER BEING INTRODUCED DURING IMPACTION, SUBSEQUENTLY LEADING TO CRACK INITIATION, PROPAGATION, AND ULTIMATE FRACTURE OF THE DEVICE. THE CONTRIBUTIONS OF REPROCESSING TO THE MATERIAL FAILURE CANNOT BE DETERMINED BECAUSE NO DEVICES WERE RETURNED FOR EVALUATION AND REPROCESSING INFORMATION WAS NOT PROVIDED. 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. THERE IS NO REPORTED PATIENT IMPACT. NO SPECIFIC CASE IS MENTIONED BY THE AGENT. AN INVESTIGATION WAS CONDUCTED; THE MOST LIKELY UNDERLYING CAUSE FOR THE FRACTURED SPECIAL QUICK IMPACTOR REPORTED IS A STRESS-RISER BEING INTRODUCED DURING IMPACTION, SUBSEQUENTLY LEADING TO CRACK INITIATION, PROPAGATION, AND ULTIMATE FRACTURE OF THE DEVICE. THE CONTRIBUTIONS OF REPROCESSING TO THE MATERIAL FAILURE CANNOT BE DETERMINED BECAUSE NO DEVICES WERE RETURNED FOR EVALUATION AND REPROCESSING INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE US THAT THE IMPACTOR TIPS WORK WELL BUT EVENTUALLY BREAK UPON IMPACT. THE AGENT BELIEVE THAT THIS IS DUE TO AUTOCLAVING THE INSTRUMENTS AND THE HEAT WEAKENING THEM OVERTIME. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303925 EXACTECH QUICK IMPACTOR RADEL BARNARD LXH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown