BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14074251 · Received April 11, 2022

    Report

    Report Number
    1038671-2022-00405
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    August 20, 2019
    Report Date
    April 25, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. INFORMATION WAS NOT PROVIDED FOR: PT. INFO. THE LOT NUMBER WAS NOT REPORTED; THEREFORE IT CAN¿T BE CONFIRMED IF THIS DESIGN WAS MANUFACTURED PRIOR TO THE DESIGN UPDATE. HOWEVER, A REVIEW OF ALL PREVIOUS COMPLAINTS REGARDING THIS DEVICE REVEALED THAT ALL BROKEN TRULIANT FEMORAL TRIAL EXTRACTORS WERE DUE TO A WELD FAILURE FROM DEVICES MANUFACTURED AS A MULTI-PIECE CONSTRUCTION. 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. 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. 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 (B)(4) 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 (B)(4) FOR ADDITIONAL DETAILS, CALCULATION, AND MODEL COMPARISONS.

    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 SURGEON EXPERIENCED AN ISSUE WITH THE INSTRUMENTATION. THEN THE FEMORAL TRIAL EXTRACTOR BROKE AS THE PHYSICIAN WAS REMOVING THE FEMORAL TRIAL. IT APPEARS THE SPRING BROKE. NOTHING WAS LEFT IN THE PATIENT. THE PATIENT WAS STABLE AS THEY LEFT THE OR. THIS DID NOT CAUSE A SIGNIFICANT DELAY TO THE CASE. IT WAS LESS THAN 5 MINUTES. THERE WAS NO REPORTED PATIENT INJURY. THE REP WAS PRESENT AT THE TIME OF THE SURGERY. THE DEVICES WERE NOT RECEIVED IN COMPLAINTS AND THE REP COULD NOT PROVIDE ANY TRACKING INFORMATION. INACTIVE AGENCY WITH NO HOSPITAL/OTHER CONTACT INFORMATION FOR THE EVENT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489007 EXACTECH TRUL FEM TRIAL EXTRACTOR LHX EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown