BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24758052 · Received April 1, 2026

    Report

    Report Number
    8030965-2026-03059
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 14, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    10886982336354
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT ' 03.527.206, 2.7 VOLT(TM) CRTX/LCKNG DRL GD F/2.0 DB HAS BROKEN INTO PIECES . THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 2.7 VOLT(TM) CRTX/LCKNG DRL GD F/2.0 DB WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE ¿2.7 VOLT(TM) CRTX/LCKNG DRL GD F/2.0 DB¿ HAS BROKEN INTO PIECES BECAUSE OF UNINTENDED FORCE, AND 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 DEPUY SYNTHES 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 PART # 03.527.206 SYNTHES LOT # 3253509 SUPPLIER LOT # 3253509 RELEASE TO WAREHOUSE DATE: 21 JUL 2025 EXPIRATION DATE; NA SUPPLIER: VIANT (B)(4). NO NCR'S GENERATED DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON MARCH 14, 2026 DURING AN ORIF OF FEMUR THE DRILL GUIDE BROKE AND WAS UNABLE TO USE. ALSO, VOLT DEPTH GAUGE STEM WAS BENT BEYOND REPAIR. BOTH INSTRUMENTS WERE REPLACED FROM OTHER SETS QUICKLY WITH MINIMAL DELAY TO THE CASE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211853 2.7 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 2.0MM DRILL BITS GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 3253509 10886982336354

    Patients

    Seq Age Sex Outcome Treatment
    1