BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 TI CORT FIX 7X40MM

    MDR report key: 15085949 · Received July 22, 2022

    Report

    Report Number
    1526439-2022-01266
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 24, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    UDI-DI
    10705034352008
    PMA / PMN Number
    K160904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL PRODUCT CODE: NKB,KWQ,KPW AND MNI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 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. INVESTIGATION SUMMARY: 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 THERE WAS NO DAMAGE OR DEFECTS WITH THE 5.5 TI CORT FIX 7X40MM. MIGRATION/BACKOUT/PULL-OUT CONDITION COULD BE NOT CONFIRMED SINCE X-RAY EVIDENCE WAS NOT PROVIDED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE 5.5 TI CORT FIX 7X40MM DUE TO THE DESIGN OF THE DEVICE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO EXCESSIVE/UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE 5.5 TI CORT FIX 7X40MM WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 186731740, LOT NUMBER: 338223; NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PLIF (L4-5) FOR TREATING SPONDYLOLISTHESIS ON (B)(6) 2022 THE 7.0X 40MM SCREW (UNK) CUT OUT DURING SCREW TIGHTENING (WIPER MOTION) WITH THE TORQUE WRENCH IN QUESTION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT (7.0X 45MM SCREW) LESS THAN 30-MINUTE SURGICAL DELAY. HE COMMENTED THAT THE EVENT MIGHT HAVE BEEN TRIGGERED BY MALFUNCTIONING TORQUE-VALUE SETTING ON THE TORQUE WRENCH. IT WAS BECAUSE AN EXCESSIVE LOAD HAD BEEN UNEXPECTEDLY PUT ONTO THE SCREW. WHEN THE SURGEON WAS APPLYING THE REPLACEMENT, HE ALSO FELT STRONG LOAD EVEN BEFORE TORQUE CAME INTO ACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 7X40MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88867 5.5 TI CORT FIX 7X40MM ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH 186731740 338223 10705034352008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown