BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED FORCEPS SERRATED JAW-RATCHET 144

    MDR report key: 23657571 · Received November 26, 2025

    Report

    Report Number
    8030965-2025-11901
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 2, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    UDI-DI
    10886982203175
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(6). 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. ADDITIONAL NARRATIVE: H6: PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT RED FORCEPS SERRATED JAW-RATCHET 144 , THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THE IMAGE ATTACHED DOESN'T SHOW THE COMPLETE DEVICE 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 OBSERVED CONDITION OF THE RED FORCEPS SERRATED JAW-RATCHET 144 WOULD NOT CONTRIBUTE 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 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. H3, H4, H6: DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: PART NUMBER: 399.99 LOT NUMBER: T170330 MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 12-SEP-2018 A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND A NC WAS STARTED BECAUSE THE LASER POINT FOR SCREW LOCKING MANUFACTURED BY THE SUPPLIER HAD A CRACK ON 10 FROM 100 INSTRUMENTS. THE DEFECTIVE INSTRUMENTS WERE SCRAPPED. THE NECESSARY ACTIONS TO ENSURE THE FINAL PRODUCT QUALITY HAVE BEEN TAKEN AND DOCUMENTED IN THE APPROPRIATE QUALITY SYSTEM. THE NC HAVE NO IMPACT TO THE COMPLAINT CONDITION. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. 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 CLAMP IS BROKEN. THE ISSUE WAS DISCOVERED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030276 RED FORCEPS SERRATED JAW-RATCHET 144 FORCEPS HTD SYNTHES GMBH T170330 10886982203175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown