BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE RESECT PROTECTOR,SZ L/50.0MM

    MDR report key: 18258012 · Received December 4, 2023

    Report

    Report Number
    1220246-2023-09133
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 7, 2023
    Report Date
    November 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867060388
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9401-50 BATCH 051838 WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, IT WAS NOTED THAT THE INSTRUMENT HAS MANY DISCOLORATION SPOTS AND RUST/CORROSION. NICKS WERE OBSERVED ON THE EDGES. THE MOST LIKELY CAUSE OF THE REPORTABLE FAILURE COULD BE USING THE INCORRECT CLEANING PROCESS. PER DFU-0023-7 AT REVISION 0. F. CLEANING. CAUTION: LOW ACID OR HIGH ALKALINE SOLUTIONS ARE NOT RECOMMENDED, AS THEY CORRODE METAL PARTS AND ANODIZED ALUMINUM AND COMPROMISE POLYMER PLASTICS, SUCH AS FEP (FLUORINATE DETHYLENEPROPYLENE), ABS (ACRYLONITRILE BUTADIENE STYRENE), ULTEM¿, LEXAN¿, AND CYCOLAC¿. IF NON-NEUTRAL PH CLEANING CHEMISTRIES ARE UTILIZED, CARE SHOULD BE TAKEN TO ENSURE APPROPRIATE RINSING, AS VALIDATED BY THE END-USER FACILITY, AND NEUTRALIZATION STEPS ARE TAKEN SO AS TO NOT NEGATIVELY IMPACT THE FIT, FINISH, OR FUNCTION OF THE DEVICE. CLEANING SOLUTIONS SHOULD ALWAYS BE MIXED TO THE MANUFACTURER¿S SPECIFICATION FOR CONCENTRATION, AND CLEANING SHOULD BE CONDUCTED AT AMBIENT TEMPERATURE UNLESS OTHERWISE STATED IN THE CLEANING SOLUTION MANUFACTURER¿S INSTRUCTIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9401-17 HUMERAL HEAD EXTRACTOR TIP WAS CHIPPED, AND AN AR-9401-50 RESECTION PROTECTOR WAS RUSTED. THIS WAS DISCOVERED BEFORE USE IN A CASE UPON OPENING THE TRAY AND WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159725 ECLIPSE RESECT PROTECTOR,SZ L/50.0MM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. ECLIPSE RESECT PROTECTOR,SZ L/50.0MM 051838 00888867060388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown