BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4

    MDR report key: 17192554 · Received June 23, 2023

    Report

    Report Number
    8030965-2023-07983
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    April 26, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819806511
    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 SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. H3, H4, H6: DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 400.834.04S LOT NUMBER: 2027P31 IT WAS ELECTRONICALLY REVIEWED, AND NO NONCONFORMANCE'S/MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 03/09/2022 MANUFACTURING SITE: JABIL BETTLACH EXPIRY DATE:01/09/2032 THE PRODUCT WAS RETURNED TO DEPUY SYNTHESE FOR EVALUATION. THE DEPUY SYNTHESE TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 WAS BROKEN FROM THE HEAD OF THE SCREW. BROKEN PORTION WAS NOT RETURNED. NO OTHER DEFECT WAS FOUND. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING 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 SYNTHESE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED 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 SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT DURING A CRANIOPLASTY PROCEDURE ON (B)(6) 2023, IT WAS NOTED THAT THE CROSS HEAD OF THE SCREW WAS BROKEN WHEN THE PACKAGE WAS OPENED. THE SURGEON CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO DELAY IN SURGERY. UPON PRODUCT INVESTIGATION COMPLETED ON (B)(6) 2023, IT WAS FOUND THAT THE SCREWS WERE BROKEN FROM THE HEAD. THIS REPORT INVOLVES ONE CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853750 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 SCREW, FIXATION, BONE HWC SYNTHES GMBH 2027P31 07611819806511

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4