BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14279280 · Received May 4, 2022

    Report

    Report Number
    1038671-2022-00514
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 29, 2019
    Report Date
    May 3, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. SEOUL, KOREA. DESIGN-RELATED ISSUES: THE DESIGN OF THE DRILL GUIDE HANDLE HAS BEEN IN THE FIELD SINCE 2004. EXACTECH IS AWARE OF 5 SIMILAR COMPLAINT REPORTS INVOLVING BROKEN DRILL GUIDE HANDLES DUE TO FRACTURED THREADS SINCE 2008. BECAUSE THE DRILL GUIDE HANDLE IS USED IN BOTH ANATOMIC AND REVERSE SHOULDER SURGERIES, SALES DATA FOR 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: EXACTECH IS NOT AWARE OF ANY OTHER COMPLAINTS INVOLVING PARTS FROM THIS MANUFACTURING LOT OF 30 UNITS, WHICH HAS BEEN IN THE FIELD SINCE 2015. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT (RMR) AND RISK ASSESSMENT AND CONTROLS REPORT (RACR) WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESHOLD. THE RMR AND RACR FOR THIS DRILL GUIDE HANDLE, RMR-00006 REV ¿ AND RACR-00009 REV, WERE REVIEWED. THE RISK IS CAPTURED, HOWEVER THE RACR IS BEING UPDATED UNDER DCRSP-19-541 TO CAPTURE AN APPROPRIATE HARM FOR THIS HAZARDOUS SITUATION. CORRECTIVE ACTIONS ARE NOT REQUIRED BECAUSE THE OCCURRENCE RATE IS ¿VERY LOW¿, THE RISK IS CAPTURED IN THE RMR AND RACR, AND THE HARM WILL BE UPDATED. THE BROKEN INSTRUMENT REPORTED WAS LIKELY THE RESULT OF APPLYING AN OFF-AXIS TORQUE TO THE HANDLE DURING USE WHICH ALLOWED THE THREADS TO FRACTURE. HOWEVER; THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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. DEVICE(S) 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. THERE IS NO REPORTED PATIENT ADVERSE EVENT DUE TO THE BROKEN DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM OUS THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON EXPERIENCED AN ISSUE WITH THE INSTRUMENTATION. THE DRILL GUIDE HANDLE BROKE DURING INSERTION. NO PARTS/PIECES FELL INTO THE SURGICAL SITE. THERE WAS NO DELAY AND NO INJURY/CLINICAL CONSEQUENCE/ADVERSE EVENT. MAGES WERE PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REQUEST FOR ADDITIONAL INFORMATION WAS SENT TO THE REP AND A RESPONSE WAS RECEIVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE FROM THE CONTACTS ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244032 EXACTECH DRL GD HNDL LHX EXACTECH, INC. 70125014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown