BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE KIT 2.8MM SHOULDER Q-FIX

    MDR report key: 18149983 · Received November 16, 2023

    Report

    Report Number
    3006524618-2023-00443
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 26, 2023
    Report Date
    October 1, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    LXH
    UDI-DI
    00885556724651
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. HOWEVER, AN IMAGE EVALUATION WAS PERFORMED AND FOUND THREE IMAGES SHOWING DIFFERENT ANGLES OF THE PACKAGING AND THE DEVICE. THE FIRST ONE IS A UPPER VIEW, SHOWING THE LABEL WITH THE PART NUMBER 25-2810 AND LOT 2106117., WITH THE PACKAGING WRINKLED. THE SECOND IMAGE IS A RIGHT VIEW OF THE PACKAGING SHOWING THE PACKAGING SHRINK AWAY, WITH SINGS OF ROUGH HANDLING AND EXPOSURE TO HEAT. THE THIRD IMAGE IS A LEFT VIEW, SHOWING COMPLETELY ALL PARTS SHRINK AWAY OF THE PACKING. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. THE COMPLAINT WAS ESCALATED TO THE MANUFACTURING TEAM AND AFTER REVIEW HAS DETERMINED NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME AS AT THE PACKAGING AREA THERE ARE NO HEAT RELATED OPERATIONS AS THE DEVICES ARE ONLY PUT INTO THE WHITE BOXES, AND ALL 100% SEALED TRAYS ARE INSPECTED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE (B)(4). H3, H6: PART OF THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED NO ORIGINAL PACKAGING WAS RETURNED FOR INSPECTION. THE DRILL, DRILL GUIDE, AND THE OBTURATOR WERE RETURNED. THE DRILL GUIDE HAS BIO DEBRIS ON IT. AN IMAGE EVALUATION WAS PERFORMED AND FOUND THREE IMAGES SHOWING DIFFERENT ANGLES OF THE PACKAGING AND THE DEVICE. THE FIRST ONE IS A UPPER VIEW, SHOWING THE LABEL WITH THE PART NUMBER 25-2810 AND LOT 2106117., WITH THE PACKAGING WRINKLED. THE SECOND IMAGE IS A RIGHT VIEW OF THE PACKAGING SHOWING THE PACKAGING SHRINK AWAY, WITH SINGS OF ROUGH HANDLING AND EXPOSURE TO HEAT. THE THIRD IMAGE IS A LEFT VIEW, SHOWING COMPLETELY ALL PARTS SHRINK AWAY OF THE PACKING. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE DAMAGE DURING SHIPPING, MISHANDLING OR EXCESSIVE EXPOSURE TO HIGH ENVIRONMENTAL TEMPERATURES. THE COMPLAINT WAS ESCALATED TO THE MANUFACTURING TEAM AND AFTER REVIEW HAS DETERMINED NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SHOULDER Q-FIX KIT, WHEN OPENED FROM THE SEALED BOX, HAD HEAT DAMAGE TO THE PACKAGING CAUSING THE PLASTIC TO SHRINK AWAY FROM THE SEAL. IT WAS NOT USED AS IT WAS NOT STERILE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544668 DISPOSABLE KIT 2.8MM SHOULDER Q-FIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROCARE CORPORATION 2106117 00885556724651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown