BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATION/DISSECTION INSTRUMENTS

    MDR report key: 15695148 · Received October 29, 2022

    Report

    Report Number
    2031966-2022-00229
    Event Type
    Malfunction
    Date Received
    October 29, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 28, 2022
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    ETN
    UDI-DI
    00887517350350
    PMA / PMN Number
    K112709
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED BY NUVASIVE AND THE COMPLAINT WAS CONFIRMED AS THE TIP OF THE DEVICE WAS FOUND TO BE FRACTURED. NO TORQUE HANDLE INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE SURGEON UTILIZED A FREEHAND TECHNIQUE. EXAMINATION OF THE RETURNED DEVICE IDENTIFIED EXCESSIVE USE FATIGUE FRACTURE. THE ROOT CAUSE OF THE TIP FRACTURE IS CONSIDERED TO BE THE RESULT OF EXCESSIVE USE CAUSING MATERIAL FATIGUE AS THE DEVICE HAS BEEN REPEATEDLY EXPOSED TO FORCE FOR OVER 10 YEARS AS LOT 181234 WAS RELEASED TO THE FIELD 04JAN2012. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. 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..."

    Description of Event or Problem · 0

    WHILE INSERTING A PEDICLE SCREW INTO L5, THE TIP OF THE SCREWDRIVER WAS BROKEN OFF IN THE SCREW HEAD. THE FRACTURED TIP COULD NOT BE RETRIEVED AND AS A RESULT THE TIP WAS RETAINED IN THE PATIENT. NO PATIENT HARM WAS REPORTED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2835696 STIMULATION/DISSECTION INSTRUMENTS STIMULATOR, NERVE ETN NUVASIVE, INCORPORATED 8801215 181234 00887517350350

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male