BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 13928441 · Received March 28, 2022

    Report

    Report Number
    1038671-2022-00290
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    January 14, 2020
    Report Date
    April 21, 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, (B)(4), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. DEVICE RECEIVED FOR ANALYSIS. (B)(4) AND (B)(4) FINDINGS: IN CASE OF MULTI-PIECE CONSTRUCTION, IT WAS FOUND THAT THE WELD ON THE EXTRACTOR BODY WAS BREAKING. THIS ALLOWED THE COMPONENT PARTS TO DISASSEMBLE. THE ENGINEERING PRINT FOR THE FEMORAL TRIAL EXTRACTOR (02-029-219-1202 REV A) ALLOWED FOR ¿SINGLE OR MULTIPLE PIECE CONSTRUCTION¿ (NOTE 2). HOWEVER, THE PRINT DID NOT SPECIFY HOW TO WELD/ASSEMBLE THE DEVICE IF MULTIPLE-PIECE CONSTRUCTION WAS TO BE USED. CORRECTIVE ACTION TAKEN: INITIALLY, THE SUBCOMPONENT PRINT (02-029-219-1202 REV A) WAS UPDATED (TO REV B) TO IDENTIFY AND DEFINE THE TOLERANCE AND DIMENSION FOR A MULTIPLE-PIECE CONSTRUCTION. DOWEL PINS ARE WELDED IN PLACE SO THAT THE MULTIPLE PIECE ASSEMBLY APPEARS AND FUNCTIONS AS A SINGLE PIECE ASSEMBLY. REFER TO DCRTC-19-0402 FOR ADDITIONAL DETAILS. THE SUBCOMPONENT PRINT (02-029-219-1202 REV B) WAS UPDATED A SECOND TIME (TO REV C) TO REMOVE THE OPTION OF MULTIPLE-PIECE CONSTRUCTION AND ONLY ALLOW FOR SINGLE-PIECE CONSTRUCTION. BY KEEPING THE WHOLE SUBCOMPONENT AS A SINGLE-PIECE CONSTRUCT, THE FORCE REQUIRED TO BREAK THE SUBCOMPONENT IS OVER 13 TIMES THE PREVIOUS MULTIPLE-PIECE DESIGN. OTHER THAN THE STRUCTURAL STRENGTH ENHANCEMENT, THE SINGLE-PIECE DESIGN HAS IDENTICAL INTERFACE WITH MATING DEVICES AS THE PREVIOUS DESIGN WITH MINOR CHANGES ON NON-FUNCTIONAL AREAS FOR BETTER MANUFACTURABILITY. REFER TO DCRTC-19-0692 FOR ADDITIONAL DETAILS, CALCULATION, AND MODEL COMPARISONS. MOST LIKELY UNDERLYING CAUSE/ROOT CAUSE: BASED ON THE CAPA(B)(4) AND (B)(4), THE BROKEN DEVICE REPORTED WAS THE LIKELY RESULT OF THE ENGINEERING PRINT 02-029-219-1202 REV A NOT SPECIFYING DETAILS REGARDING HOW TO ASSEMBLE THE PIECES IF MULTIPLE-PIECE CONSTRUCTION WAS TO BE USED. 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 THIS EVENT LED TO PATIENT ADVERSE EVENT. IN CASE OF MULTI-PIECE CONSTRUCTION, IT WAS FOUND THAT THE WELD ON THE EXTRACTOR BODY WAS BREAKING. THIS ALLOWED THE COMPONENT PARTS TO DISASSEMBLE. BASED ON (B)(4) AND (B)(4), THE BROKEN DEVICE REPORTED WAS THE LIKELY RESULT OF THE ENGINEERING PRINT 02-029-219-1202 REV A NOT SPECIFYING DETAILS REGARDING HOW TO ASSEMBLE THE PIECES IF MULTIPLE-PIECE CONSTRUCTION WAS TO BE USED.

    Additional Manufacturer Narrative · 0

    H11. 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. THIS MEDWATCH IS BEING RESCINDED: UPON FURTHER REVIEW OF REPORTABILITY- IF THE MALFUNCTION WERE TO RECUR, IT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. THE DISASSEMBLED PARTS ARE NOT LIKELY TO FALL INTO THE WOUND SITE OR INTERFERE WITH THE SURGICAL IMPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE US THAT DURING AN ORTHOPEDIC SURGERY THE FEMORAL TRIAL EXTRACTOR BROKE. IT WAS STATED THAT NO PIECES FELL INTO THE SURGICAL SITE. NO DELAY TO SURGERY AND NO ADVERSE EVENT TO PATIENT. THERE WERE NO NOTED PROBLEMS FOR THE PATIENT IN THE OVERALL PROCEDURE OUTCOME/RESULT. IN CASE OF MULTI-PIECE CONSTRUCTION, IT WAS FOUND THAT THE WELD ON THE EXTRACTOR BODY WAS BREAKING. THIS ALLOWED THE COMPONENT PARTS TO DISASSEMBLE. 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
    927415 EXACTECH TRUL FEM TRIAL EXTRACTOR LXH EXACTECH, INC. 126008002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown