BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4

    MDR report key: 17181313 · Received June 22, 2023

    Report

    Report Number
    8030965-2023-07841
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    April 26, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    UDI-DI
    07611819806511
    PMA / PMN Number
    K022012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. E3: INITIAL REPORTER IS A SYNTHES EMPLOYEE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 400.834.04S, LOT #1707P57. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 15/09/2022, MANUFACTURING SITE: JABIL BETTLACH, EXPIRY DATE:01/09/2032. 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 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 WAS BROKEN IN TWO PIECES. BOTH PIECES WERE RETURNED FOR EVALUATION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 DUE TO POST MANUFACTURED DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED YES AS THE OBSERVED CONDITION OF THE CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 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. 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 CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE CROSS HEAD OF THE SCREW IN QUESTION WAS FOUND TO BE BROKEN UPON OPENING THE PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217746 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 PLATE, BONE JEY SYNTHES GMBH 1707P57 07611819806511

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown