BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 1.5MM DRILL BITS

    MDR report key: 22089608 · Received May 27, 2025

    Report

    Report Number
    8030965-2025-05233
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    March 28, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    10886982336248
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: H3, H6: PART: 03.420.156 SYNTHES LOT: J017967 SUPPLIER LOT: 79413811-J017967 SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 29 JANUARY 2025 NO NONCONFORMANCE REPORTS (NCRS) GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE DEVICE BROKEN FROM ONE OF THE LATERAL DRILL GUIDES. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE DEVICE ARRIVED WITHOUT PACKAGING, THEREFORE, THE ALLEGATION UPON RECEIPT CANNOT BE CONFIRMED. ONCE THE PRODUCT LEAVES J&J MEDTECH ORTHOPEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF J&J MEDTECH ORTHOPAEDICS' CONTROL. 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 2.0 VOLT(TM) CRTX/LCKNG DRL GD F/1.5 DB WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. 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 REPORTED 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. THE DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOSPITAL PURCHASED A NEW VOLT MINI FRAG AND FOUND THAT ITEM 2.0 VOLT CRTX/LCKNG DRILL GUIDE FOR 1.5MM DRILL BITS WAS BROKEN IN THE PACKAGING. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326999 2.0 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 1.5MM DRILL BITS GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH J017967 10886982336248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown