BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 12712953 · Received October 28, 2021

    Report

    Report Number
    1038671-2021-10047
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    April 13, 2017
    Report Date
    October 27, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS. DESIGN: THE DESIGN OF THE SHOULDER GPS VIX BIT HAS BEEN IN THE FIELD SINCE 2015. EXACTECH HAD NOT RECEIVED ANY OTHER COMPLAINT REPORTS INVOLVING THIS DEVICE SINCE ITS INTRODUCTION. BECAUSE THIS DEVICE IS USED IN TOTAL SHOULDER SURGERIES UTILIZING THE GPS SYSTEM, DATA FROM THE GPS WEB STATION FILE WAS USED TO CALCULATE AN APPROXIMATE COMPLAINT RATE OF <0.5%, THIS IS CONSIDERED TO BE "VERY LOW" ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE. A CORRECTIONS AND REMOVAL COMMITTEE (CRC) MEETING WAS HELD; REFER TO (B)(4) FOR DETAILS. A CAPA WAS ALSO OPENED TO ADDRESS THE ISSUE. A RECALL OF THIS DEVICE WAS PERFORMED AND WAS COMPLETED AS OF 20 OCT 2017; REFER TO CAPA(B)(4). MANUFACTURING: AS EXACTECH HAD NOT RECEIVED ANY OTHER COMPLAINTS INVOLVING THIS DEVICE, THE 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 CONFIRM THE RISK WAS INCLUDED AND THE RATE OF OCCURRENCE IS BELOW THE PREDICTED THRESHOLD. THE RMR FOR THIS SHOULDER GPS VIX BIT, 750-2010-025-RMR REV C WAS REVIEWED AND THE RISK IS CAPTURED IN LINE 17. MOST LIKELY CAUSE: THE BROKEN DRILL BIT WAS LIKELY THE RESULT OF TORSIONAL STRESSES EXCEEDING THE YIELD STRENGTH OF THE CROSS-SECTIONAL AREA OF THE DRILL BIT. IFU 700-096-181 STATES: 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 ALSO 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 OR DESIGN ISSUES, NOR DID IT LEAD TO ANY ADVERSE PATIENT IMPACT. AN INVESTIGATION WAS CONDUCTED; ANALYSIS OF THE RETURNED DEVICE FOUND THE ISSUE WAS LIKELY THE RESULT OF TORSIONAL STRESSES EXCEEDING THE YIELD STRENGTH OF THE CROSS-SECTIONAL AREA OF THE DRILL BIT.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM EXACTECH UK THAT DURING AN ORTHOPEDIC SURGICAL PROCEDURE THE DISTAL PORTION OF THE DRILL PIECE SHEARED OFF AND REMAINED STUCK INSIDE THE PATIENT'S GLENOID. THERE WAS ENOUGH OF THE TIP PROTRUDING OUT OF THE BONE THAT THE SURGEON WAS ABLE TO RETRIEVE IT. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED EVENT IS RELATED TO ANY MANUFACTURING OR DESIGN ISSUES, NOR DID IT LEAD TO ANY ADVERSE PATIENT IMPACT. AN INVESTIGATION WAS CONDUCTED; ANALYSIS OF THE RETURNED DEVICE FOUND THE ISSUE WAS LIKELY THE RESULT OF TORSIONAL STRESSES EXCEEDING THE YIELD STRENGTH OF THE CROSS-SECTIONAL AREA OF THE DRILL BIT. NO ADDITIONAL INFORMATION TO FURTHER INVESTIGATE THIS EVENT WAS PROVIDED BY THE CONTACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611793 EXACTECH 3.2MM VIX BIT LXH EXACTECH, INC. 75296003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention