BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4

    MDR report key: 21706817 · Received March 27, 2025

    Report

    Report Number
    8030965-2025-02829
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    December 3, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZL
    UDI-DI
    07611819806511
    PMA / PMN Number
    K031807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. E1 INITIAL REPORTER FACILITY NAME: (B)(6). H3, H6: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 400.834.04S, LOT NUMBER: 9196P54. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 06 FEB2024, MANUFACTURING SITE: JABIL BETTLACH, EXPIRY DATE: 01 2034. THE PHOTO WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 IS NOT CLEARLY OBSERVED IN THE PHOTO DUE TO POOR QUALITY. AND NO OBSERVATIONS PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS ATTACHED ARE INSUFFICIENT TO DRAW A CONCLUSION ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: SCREW BREAKAGE. IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN (AS THE PHOTO SHOWS), ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 WAS BROKEN, ONLY TWO PARTS OF THE HEAD WAS RETURNED FOR INVESTIGATION. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EXAMINATION. HOWEVER, THE FRACTURE SURFACE WAS THOROUGHLY EXAMINED ON THE SCREW AND NO PROBLEMS WITH THE MATERIAL WERE NOTED. THE OBSERVED CONDITION IS CONSISTENT WITH A TORSIONAL FAILURE WHICH IS LIKELY DUE TO THE APPLICATION OF SIGNIFICANT TORQUE DURING THE IMPLANTATION PROCESS. ACCORDING TO THE LOW PROFILE NEURO SURGICAL TECHNIQUE GUIDE THE FOLLOWING WARNINGS ARE MENTIONED: - THESE DEVICES CAN BREAK DURING USE (WHEN SUBJECTED TO EXCESSIVE FORCES OR OUTSIDE THE RECOMMENDED SURGICAL TECHNIQUE). WHILE THE SURGEON MUST MAKE THE FINAL DECISION ON REMOVAL OF THE BROKEN PART BASED ON ASSOCIATED RISK IN DOING SO, WE RECOMMEND THAT WHENEVER POSSIBLE AND PRACTICAL FOR THE INDIVIDUAL PATIENT, THE BROKEN PART SHOULD BE REMOVED. - BE AWARE THAT IMPLANTS ARE NOT AS STRONG AS NATIVE BONE. IMPLANTS SUBJECTED TO SUBSTANTIAL LOADS MAY FAIL. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE WAS CONSISTENT WITH THE REPORTED CONDITION. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO THE APPLICATION OF SIGNIFICANT TORQUE DURING IMPLANTATION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 400.834.04S. LOT NUMBER: 9196P54. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 06 FEB 2024. MANUFACTURING SITE: JABIL BETTLACH. EXPIRY DATE:01 JAN 2034. 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

    IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470645 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4 SCREW, FIXATION, INTRAOSSEOUS DZL SYNTHES GMBH 9196P54 07611819806511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown