BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14013812 · Received April 5, 2022

    Report

    Report Number
    1038671-2022-00372
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    July 11, 2019
    Report Date
    April 5, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. FINDINGS: THE FRACTURED HEAD OF THE MINI HEADED FIXATION PIN MAY HAVE BEEN THE RESULT OF APPLYING A BENDING MOMENT TO THE PROXIMAL HEAD OF THE PIN WITH THE PIN PULLER INSTRUMENT. TENSION WAS LIKELY APPLIED TO THE PIN PULLER AT AN ANGLE RATHER THAN AXIALLY AS INTENDED. THE PATIENT WAS REPORTED STABLE LEAVING THE OPERATING ROOM AND NO PIECES WERE LEFT IN THE PATIENT. MOST LIKELY UNDERLYING CAUSE: BASED ON PREVIOUS SIMILAR INVESTIGATIONS, THE BROKEN PIN REPORTED WAS LIKELY THE RESULT OF APPLYING A BENDING MOMENT TO THE HEAD OF THE PIN WITH THE PIN PULLER, WHICH ALLOWED FOR THE PROXIMAL RIM TO FRACTURE. RMR REVIEW: THE RMRS FOR THESE MINI HEADED FIXATION PINS, 750-2001-029-RMR-INSTRUMENTS REV D AND 750-2003-019-RMR-INSTRUMENTS REV B, WERE REVIEWED. THE RISK IS CAPTURED. 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. THERE IS NO REPORTED PATIENT ADVERSE EVENT, THE BROKEN PIN HEAD IS MATERIAL FATIGUE/DEBRIS. AN INVESTIGATION WAS CONDUCTED: BASED ON PREVIOUS SIMILAR INVESTIGATIONS, THE BROKEN PIN REPORTED WAS LIKELY THE RESULT OF APPLYING A BENDING MOMENT TO THE HEAD OF THE PIN WITH THE PIN PULLER, WHICH ALLOWED FOR THE PROXIMAL RIM TO FRACTURE.

    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 HOLDING PIN HEAD WAS BROKEN. THE BROKEN PIN HEAD IS MATERIAL FATIGUE/DEBRIS. THE SURGERY WAS COMPLETED, AND THE PATIENT IS FINE. NO PIECES WERE LEFT IN THE PATIENT. NEW INFORMATION 27 JUL 2021: DAMAGE WAS DETECTED AFTER THE SURGERY. NO PIECES FELL INTO THE SURGICAL SITE. THERE WAS NO SURGICAL DELAY OR PATIENT IMPACT. NO OTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS ABOUT THE DEVICE/EVENT/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919214 EXACTECH MINI HEADED FIXATION PIN REPLACED BY 201-78-15 LXH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male