BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFCSIG POSTLIP TRIAL 10MM SZ4

    MDR report key: 18552459 · Received January 22, 2024

    Report

    Report Number
    1818910-2024-01515
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    November 22, 2023
    Report Date
    January 22, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295236382
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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, DAMAGED TRIAL LINER. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTO WAS PROVIDED FOR REVIEW. SEE ATTACHMENT (B)(4) - PPG BROKEN INSERT 4 10MM PFC. THE PHOTO INVESTIGATION REVEALED THAT DEVICE 961251, PFCSIG POSTLIP TRIAL 10MM SZ4 HAD SURFACE WORN OUT, BROKEN CONDITION CAN BE SEEN AT RIGHT SIDE FROM THE PROVIDED EVIDENCE. BASED ON THE AVAILABLE EVIDENCE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 961251, PFCSIG POSTLIP TRIAL 10MM SZ4 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. 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 TRIAL LINER WAS DAMAGED. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO . DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? N/A. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. DAMAGED TRIAL LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452732 PFCSIG POSTLIP TRIAL 10MM SZ4 TIBIAL INSERT TRIALS HWT DEPUY ORTHOPAEDICS INC US 10603295236382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown