BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 12712969 · Received October 28, 2021

    Report

    Report Number
    1038671-2021-10059
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    June 29, 2018
    Report Date
    October 28, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS. ENG EVAL COMPLETED ON 06/19/2019 BY (B)(4). A CRC MEETING WAS HELD TO ASSESS THE FAILURE OF THE TRULIANT SYRINGE PIN PULLER. THE COMMITTEE DETERMINED THAT BASED ON THE LOW RISK TO HEALTH THAT NO FIELD ACTION IS NECESSARY -(B)(4) FOR DETAILS. FURTHER INVESTIGATION WILL BE CONDUCTED UNDER CAPA(B)(4). DESIGN-RELATED ISSUES: THE DESIGN OF THE TRULIANT SYRINGE PIN PULLER HAS BEEN IN THE FIELD SINCE 2017. (B)(4). 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 AWARE OF 1 OTHER COMPLAINT INVOLVING PARTS FROM THIS MANUFACTURING LOT OF (B)(4) UNITS. A REVIEW OF FOUR NPRS RELATED TO TRULIANT SYRINGE STYLE PIN PULLERS (CATALOG #02-029-90-4100) WAS CONDUCTED. HOWEVER, NONE OF THESE NPRS APPEAR TO BE RELATED TO THE FAILURE MODE REPORTED IN THIS COMPLAINT. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING RELATED. MOST LIKELY UNDERLYING CAUSE: THE BROKEN INSTRUMENT REPORTED THIS EVENT WAS LIKELY THE RESULT OF THE PRONGS OF THE PIN PULLER EXPERIENCING EXCESSIVE FORCES DURING THE EXTRACTION OF BONE PINS. 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 THE REPORTED EVENT IS RELATED TO ANY MANUFACTURING ISSUES OR DESIGN ISSUES. ALL THE BROKEN DEVICE PIECES WERE REMOVED FROM THE SURGICAL SITE, WITH NO REPORTED ADVERSE EVENT. AN INVESTIGATION WAS CONDUCTED; THE BROKEN INSTRUMENT REPORTED THIS EVENT WAS LIKELY THE RESULT OF THE PRONGS OF THE PIN PULLER EXPERIENCING EXCESSIVE FORCES DURING THE EXTRACTION OF BONE PINS.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE US THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON GRABBED THE HEADED PINS OUT OF THE TRIAL TIBIA THAT WAS SECURED TO THE PATIENT'S BONE. THE CLAWS THAT EXTEND OUT TO GRAB THE PIN SNAPPED OFF. TWO PIECES BROKE OFF INTO THE SURGICAL SITE, THEY WERE FOUND AND TAKEN OUT OF THE PATIENT. THERE WERE NO PIECES LEFT IN THE PATIENT. THE SURGEON THEN HAD TO FIND AN ALTERNATIVE WAY (ATTACHED THE HANDLE TO THE TRAY AND USED A HAMMER TO HIT UNDER THE HANDLE TO PROP THE TRAY AND PIN OUT) TO GET THE PIN AND TIBIAL TRAY OUT OF THE PATIENT/BONE. THE AGENT WAS PRESENT AT THE TIME OF SURGERY. THERE WAS NO DELAY TO SURGERY AND NO ADVERSE EFFECT TO THE PATIENT. THE PATIENT WAS STABLE AND FINE LEAVING THE OR. THE AGENCY IS INACTIVE, THERE IS NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612118 EXACTECH TRULIANT PIN PULLER, SYRINGE STYLE LXH EXACTECH, INC. 93388007

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention