BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 EXP VERSE SCREW 7.0 X 50

    MDR report key: 10180942 · Received June 22, 2020

    Report

    Report Number
    1526439-2020-01224
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 8, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034442099
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6: THE DEVICE HISTORY RECORD (DHR) OF PRODUCT CODE 199721750, LOT 223239 WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON NOVEMBER 10, 2018. VISUAL INSPECTION: THE 5.5 EXP VERSE SCREW 7.0 X 50 WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE PROXIMAL PORTION OF THE SCREW TAB ON THE SIDE OF THE PART/LOT NUMBER ETCHED IS BROKEN AND THE BROKEN FRAGMENT WAS NOT RETURNED. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE OUTER DIAMETER OF THE SCREW HEAD WAS MEASURED TO BE WITHIN THE SPECIFICATION. THE INNER DIAMETER OF THE SCREW HEAD WAS MEASURED TO BE WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. EXPEDIUM VERSE- 4.35 MM/ 8MM POLY SCREW ASSEMBLY;EXPEDIUM VERSE SCREW HEAD. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE 5.5 EXP VERSE SCREW 7.0 X 50. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: KWP, KWQ, MNH, MNI, OSH. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 1

    IT WAS REPORTED THAT DURING A SPINAL FUSION FOR A L1 BURST FRACTURE ON (B)(6) 2020, THE SURGEON WAS BREAKING THE TABS OFF A VERSE SCREW AND IN DOING SO, A PART OF THE SCREW WAS CHIPPED OFF. THE SURGEON PLACED SCREWS IN LEVELS T11 L2. SCREWS WERE PLACED SUCCESSFULLY. SPINAL RODS WERE CONTOURED AND PLACED INTO THE SCREW HEADS. SET SCREWS WERE PLACED OVER THE RODS SUCCESSFULLY. FINAL TIGHTENING OF THE SET SCREWS WAS SUCCESSFUL. THE SURGEON WENT TO BREAK THE EXTENDED TABS OFF THE SCREWS, AND ONE SCREW CHIPPED WHILE BREAKING OFF A TAB. THE SURGEON THEN REMOVED THE SET SCREW FROM THAT VERSE SCREW AND REPLACED IT WITH A NEW SCREW. THE CHIPPED PIECE OF SCREW WAS REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY (20) MINUTES. THE PATIENT WAS NOT HARMED. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 7.0 X 50. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645266 5.5 EXP VERSE SCREW 7.0 X 50 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH 199721750 223239 10705034442099

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR UNKNOWN LOCKING/SET SCREWS| UNKNOWN RODS| UNKNOWN SCREWDRIVERS