BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING HANDLE WITH QUICK COUPLING

    MDR report key: 23960053 · Received January 5, 2026

    Report

    Report Number
    8030965-2026-00084
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 16, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    10886982070814
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    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, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11. ADDITIONAL NARRATIVE: H6. COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H6: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER IN THE IMAGES PROVIDED NO OBSERVATIONS PERTAINING TO THE NATURE OF THE REPORTED EVENT OF UNABLE TO ASSEMBLE OR DISASSEMBLE COULDBE IDENTIFIED. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE PHOTOGRAPHS ATTACHED DON¿T HAVE ANY EVIDENCE 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 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 LOT: PART # 03.100.032. SYNTHES LOT # 6940263. SUPPLIER LOT # 6940263. RELEASE TO WAREHOUSE DATE: 05 JUN 2012. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW: 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. 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

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 THE HANDLE OF THE SCREWDRIVER ATTACHMENT WAS LOOSE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20491 RATCHETING HANDLE WITH QUICK COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 6940263 10886982070814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown