BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE GENERAL INSTRUMENTS

    MDR report key: 16659693 · Received March 31, 2023

    Report

    Report Number
    2031966-2023-00060
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 31, 2023
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    LXH
    UDI-DI
    00887517425836
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED, WHICH WAS USED TO CONFIRM THE REPORTED EVENT. A REVIEW OF THE DEVICE DHR IDENTIFIED THE PRODUCT WAS RELEASED TO THE FIELD IN 2012. WHILE NO DEVICE WAS AVAILABLE FOR EVALUATION, THE CAUSE OF THE REPORTED TIP FRACTURE WAS LIKELY RELATED TO EXCESSIVE, OFF-ANGLE, FORCE AND MATERIAL FATIGUE OVER MORE THAN 10 YEARS OF FIELD LIFE. NO ADDITIONAL INVESTIGATION NECESSARY. LABELING REVIEW: "...DO NOT IMPLANT THE INSTRUMENTS: COMPLICATIONS TO THE PATIENT MAY INCLUDE, BUT ARE NOT LIMITED TO: BREAKAGE OF THE DEVICE, WHICH COULD MAKE NECESSARY REMOVAL DIFFICULT OR SOMETIMES IMPOSSIBLE, WITH POSSIBLE CONSEQUENCES OF LATE INFECTION AND MIGRATION. BREAKAGE COULD CAUSE INJURY TO THE PATIENT..."; "...PRE-OPERATIVE WARNINGS: THE METHOD OF USE FOR THE INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES. THE INSTRUMENTS SHOULD BE TREATED AS ANY PRECISION INSTRUMENT AND SHOULD BE CAREFULLY PLACED ON TRAYS, CLEANED AFTER EACH USE, AND STORED, ACCORDING TO GENERALLY ACCEPTED HOSPITAL METHODS AND PRACTICES. THE INSTRUMENTS SHOULD BE CAREFULLY EXAMINED PRIOR TO USE FOR FUNCTIONALITY, EXCESSIVE WEAR, OR DAMAGE. A DAMAGED INSTRUMENT SHOULD NOT BE USED AS THIS MAY INCREASE THE RISK OF MALFUNCTION AND POTENTIAL PATIENT INJURY. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND INJURY TO THE PATIENT..."; "...INTRA-OPERATIVE WARNINGS: THE PHYSICIAN SHOULD TAKE PRECAUTIONS AGAINST PUTTING UNDUE STRESS ON THE SPINAL AREA WITH INSTRUMENTS. ANY SURGICAL TECHNIQUE SHOULD BE CAREFULLY FOLLOWED. IT IS IMPORTANT THAT THE SURGEON EXERCISE EXTREME CAUTION WHEN WORKING IN CLOSE PROXIMITY TO VITAL ORGANS, NERVES, OR VESSELS, AND THAT THE FORCE APPLIED TO THE INSTRUMENTATION IS NOT EXCESSIVE, TO PREVENT POTENTIAL INJURY TO THE PATIENT. OVER-BENDING, NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE. THE PHYSICAL CHARACTERISTICS REQUIRED FOR MANY INSTRUMENTS DO NOT PERMIT THEM TO BE MANUFACTURED FROM IMPLANTABLE MATERIALS. IF ANY BROKEN FRAGMENTS OF INSTRUMENTS REMAIN IN THE BODY OF A PATIENT, THEY COULD CAUSE ALLERGIC REACTIONS OR INFECTIONS. IF AN INSTRUMENT BREAKS IN SURGERY AND FRAGMENTS GO INTO THE PATIENT, THESE PIECES SHOULD BE REMOVED PRIOR TO CLOSURE AND SHOULD NOT BE IMPLANTED...".

    Description of Event or Problem · 0

    DURING A CASE, WHILE THE SURGEON WAS ROTATING THE PADDLE SHAVER, THE TIP FRACTURED. THE FRACTURED TIP WAS RECOVERED WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773635 NUVASIVE GENERAL INSTRUMENTS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS LXH NUVASIVE, INCORPORATED 7174007 EM0491 00887517425836

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose