BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELINE-O FINAL LOCK SCREW DRIVER

    MDR report key: 15002147 · Received July 13, 2022

    Report

    Report Number
    2031966-2022-00088
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    April 5, 2022
    Report Date
    July 13, 2022
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    UDI-DI
    00887517513724
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE REPEATED ATTEMPTS TO OBTAIN, NO ADDITIONAL EVENT INFORMATION HAS BEEN MADE AVAILABLE, NO PRODUCT HAS BEEN RETURNED FOR EVALUATION, AND NO LOT INFORMATION HAS BEEN PROVIDED. THEREFORE, A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED. PREVIOUS INVESTIGATIONS OF SIMILAR EVENTS HAVE FOUND THE EVENT TYPE MAY BE CAUSED BY EXCESSIVE AND/OR OFF AXIS FORCES BEING APPLIED DURING USE OR DURING CLEANING/STERILE PROCESSING. LABELING REVIEW: PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE POTENTIAL RISKS OF THE SURGERY. 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 DEVICE(S) 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. WHEN USING THE MAXCESS MAS TLIF SYSTEM FOR DISTRACTION CARE MUST BE TAKEN TO AVOID DAMAGING THE PEDICLES WHICH COULD COMPROMISE PEDICLE SCREW PURCHASE. 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. DEVICE LOST BY END USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TIP OF THE DRIVER BROKE OFF DURING THE PROCEDURE. IT IS UNKNOWN IF THE FRACTURED PIECE WAS RETRIEVED FROM THE WOUND. THERE WAS NO PATIENT INJURY OR ADVERSE IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638474 RELINE-O FINAL LOCK SCREW DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH NUVASIVE, INC. 10000751 NI 00887517513724

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose