BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LID

    MDR report key: 17710719 · Received September 8, 2023

    Report

    Report Number
    1818910-2023-18327
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    January 1, 2023
    Report Date
    September 8, 2023
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    FSM
    UDI-DI
    10603295258674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "THE PTA INSTRUMENT WAS RECEIVED AT THE CENTRAL STERILIZATION SERVICE, DURING THE TRACEABILITY PROCESS, IT WAS VERIFIED THAT THE STATUS OF THE TRAYS AND LID WAS ALREADY DETERIORATED: LID AND BROKEN TRAYS, WITH HOLES AND GLUE, OXIDIZED MILLS". THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT ¿20230825_172421¿, ¿20230825_172406¿, ¿20230825_172359¿, ¿20230825_172240¿, ¿20230825_172234¿, ¿20230825_172228¿, ¿20230825_172222¿, ¿20230825_172215¿ AND ¿20230825_172203¿. THE PHOTO INVESTIGATION REVEALED THAT THE L20504, LID WAS BROKEN AND SURFACE HAD TRACES OF FOREIGN SUBSTANCE, BUT IT IS NOT POSSIBLE TO CONFIRM THAT THE DEVICE WAS RUSTED BASED ON AVAILABLE EVIDENCE. BASED ON THE AVAILABLE EVIDENCE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE L20504, LID WOULD 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. DEVICE HISTORY LOT : THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LID IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898287 LID CORAIL KAR INSTRUMENTS : INSTRUMENT CASES FSM DEPUY FRANCE SAS - 3003895575 10603295258674

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown