BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE LAPIDUS PLATE, TITANIUM

    MDR report key: 19525334 · Received June 12, 2024

    Report

    Report Number
    1220246-2024-05650
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    March 12, 2021
    Report Date
    June 12, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867051706
    PMA / PMN Number
    K150456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT ALLEGATION CANNOT BE CONFIRMED WITHOUT THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO PHOTOS OF THE FAILURE WERE PROVIDED. PER THE EVENT DESCRIPTION, THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A PATIENT-SPECIFIC EVENT AND/OR INADEQUATE ANCHORING TECHNIQUE. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE AND THE BONE QUALITY ENCOUNTERED WERE NOT PROVIDED. ACCORDING TO DFU-0192 AT REVISION 6. E. WARNINGS. 6. PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE DEVICE, ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. THE APPROPRIATE ARTHREX DELIVERY SYSTEM IS REQUIRED FOR PROPER IMPLANTATION OF THE DEVICE. G. PRECAUTIONS 1. SURGEONS ARE ADVISED TO REVIEW THE PRODUCT-SPECIFIC SURGICAL TECHNIQUE PRIOR TO PERFORMING ANY SURGERY. ARTHREX PROVIDES DETAILED SURGICAL TECHNIQUES IN PRINT, VIDEO, AND ELECTRONIC FORMATS. THE ARTHREX WEBSITE ALSO PROVIDES DETAILED SURGICAL TECHNIQUE INFORMATION AND DEMONSTRATIONS. OR CONTACT YOUR ARTHREX REPRESENTATIVE FOR AN ONSITE DEMONSTRATION 2. SURGEONS MUST APPLY THEIR PROFESSIONAL JUDGMENT WHEN DETERMINING THE APPROPRIATELY SIZED DEVICE BASED ON THE SPECIFIC INDICATION, PREFERRED SURGICAL TECHNIQUE, AND PATIENT HISTORY. 3. DO NOT BEND THE PLATE NEAR THE LOCKING HOLE. BENDING THE PLATE NEAR THE LOCKING HOLE CAN DISTORT THE HOLE¿S THREADING, WHICH PROHIBITS INSERTION OF THE SCREW. 4. REPEATED BENDING OF THE PLATE AT THE SAME LOCATION, OR BY CREATING EXCESSIVE ACUTE ANGLES MAY POTENTIALLY LEAD TO PREMATURE PLATE FATIGUE, FAILURE AND OR BREAKAGE IN SITU. 5. SCREWS SHOULD BE INSERTED BY HAND AND NOT WITH POWERED EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A MEDWATCH REPORT THAT THE PATIENT HAD A MIDFOOT FUSION BY A DIFFERENT SURGEON BETWEEN 8-12 MONTHS AGO. THE FUSION SITE DID NOT FUSE DUE TO BROKEN HARDWARE (AR-8941), CAUSING TOO MUCH MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937745 LOW PROFILE LAPIDUS PLATE, TITANIUM BONE FIXATION PLATE HRS ARTHREX, INC. LOW PROFILE LAPIDUS PLATE, TITANIUM UNK 00888867051706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other