BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANCELLOUS AXON(TM) SCREW 16MM THREAD LENGTH

    MDR report key: 16334732 · Received February 9, 2023

    Report

    Report Number
    8030965-2023-01593
    Event Type
    Injury
    Date Received
    February 9, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKG
    UDI-DI
    07611819761711
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODES: MNH, MNI, KWP. PART #: 405.516. SYNTHES LOT #: 7152948. SUPPLIER LOT #: N/A. RELEASE TO WAREHOUSE DATE: 12 DEC 2012. MANUFACTURED BY: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CANCELLOUSSCR AXON Ø3.5 NEUTRAL L16 TAN WAS BROKEN ACROSS THE NECK BETWEEN THE HEAD AND THE SHAFT, THE SHAFT FRAGMENT WAS NOT RETURNED. THE BODY, SLEEVE AND HEAD OF THE SCREW REMAINS ATTACHED TO ONE OF THE FRAGMENTS OF THE ROD. THE SURFACE OF THE SCREW FRAGMENT APPEARS TO BE SMOOTHED OUT AND DEFORMED, MOST LIKELY DUE TO CONSTANT FRICTION BETWEEN THE BROKEN EDGES BEFORE REMOVAL. A DIMENSIONAL INSPECTION FOR THE CANCELLOUSSCR AXON Ø3.5 NEUTRAL L16 TAN WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CANCELLOUSSCR AXON Ø3.5 NEUTRAL L16 TAN WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED? YES, REVIEWED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY FOR MEDULLARY DECOMPRESSION WITH CERVICAL SPINE ARTHRODESIS ON (B)(6) 2017 FOR TREATMENT OF BASILAR INVAGINATION. CRANIECTOMY OF POSTERIOR FOSSA WAS PERFORMED, PLUS CERVICAL OCCIPITO FIXATION (ARNOLDCHIARI SYNDROME). ON (B)(6) 2022, IMAGING CONFIRMED A BROKEN ROD. POSTOPERATIVELY, THE PATIENT COMPLAINT OF PAIN AND LETHARGY. UPON PRODUCT INVESTIGATION ON (B)(6) 2023, IT WAS FOUND THAT THE RETURNED SCREW WAS BROKEN IN TWO PIECES. THIS REPORT INVOLVES ONE 3.5MM TI CANCELLOUS AXON(TM) SCREW 16MM THREAD LENGTH. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083617 3.5MM TI CANCELLOUS AXON(TM) SCREW 16MM THREAD LENGTH ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG SYNTHES GMBH 7152948 07611819761711

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention CANCELLOUSSCR AXON Ø3.5 NEUTRAL L14 TAN.| CANCELLOUSSCR AXON Ø3.5 NEUTRAL L14 TAN.| CANCELLOUSSCR AXON Ø3.5 NEUTRAL L16 TAN.| CANCELLOUSSCR AXON Ø3.5 NEUTRAL L16 TAN.| ROD Ø3.5 L120 TAN.| UNK SCREWS: CORTEX.| UNK SCREWS: LOCKING.