BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-LOCKING DRILL GUIDE 3.5

    MDR report key: 16903425 · Received May 10, 2023

    Report

    Report Number
    8030965-2023-06002
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07612334121967
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H3 H6 PART # 03.133.002. SYNTHES LOT # 112664. SUPPLIER LOT # 112664. RELEASE TO WAREHOUSE DATE: (B)(6) 2022. SUPPLIER: VIANT UPLAND LLC. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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 NON-LOCKING DRILL GUIDE 3.5 WAS BROKEN FROM THE 2.5 CANNULA. THE BROKEN CANNULA WAS RETURNED FOR EXAMINATION. NO OTHER ISSUES WERE FOUND. A DIMENSIONAL INSPECTION FOR THE NON-LOCKING DRILL GUIDE 3.5 WAS NOT PERFORMED AS IS NOT APPLICABLE TO THE COMPLAINT CONDITION. 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 AS THE OBSERVED CONDITION OF THE NON-LOCKING DRILL GUIDE 3.5 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. DRAWING/SPECIFICATIONS REVIEWED: THE FOLLOWING SOURCE CONTROLLED DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: -3.5MM NON-LOCKING DRILL GUIDE CURRENT AND MANUFACTURED. DIMENSIONAL INSPECTION: N/A. 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 GERMANY AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A MATERIAL DEFECT. PATIENT OUTCOMES AND CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT NON-LOCKING DRILL GUIDE 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881484 NON-LOCKING DRILL GUIDE 3.5 GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 112664 07612334121967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown