BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE BR DS W/ORTHCRD

    MDR report key: 19014752 · Received April 1, 2024

    Report

    Report Number
    1221934-2024-01030
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    February 22, 2024
    Report Date
    April 1, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001101
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H10 ADDITIONAL NARRATIVE: D10: CONCOMITANT MED PRODUCTS AND THERAPY DATES: LUPINE BR DS W/ORTHCRD DEVICE, 2/22/2024 E3: REPORTER IS A J&J SALES REPRESENTATIVE. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES MITEK FOR EVALUATION. THE DEPUY SYNTHES MITEK TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL INSPECTION FOUND THAT LUPINE BR DS W/ORTHCRD SUTURE HAD FOREIGN MATTER, PRESUMABLY BIOLOGICAL MATTER. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. NO ANOMALIES COULD BE OBSERVED. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED CONDITION OF THE LUPINE BR DS W/ORTHCRD WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE WAS NO NON CONFORMANCE REGARDING THIS LOT. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE FOR THE SUTURE CONDITION IS TRACED TO THE PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE. AS PER IFU, IN HANDLING THIS OR ANY OTHER SUTURE MATERIAL, CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM HANDLING. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. EXCESSIVE TENSION MAY OVERLOAD THE ANCHOR OR SUTURE. AS THE DEVICE SHOW SIGNS OF USE, THE REPORTED COMPLAINT OF FAILURE WITHOUT USE CANNOT BE CONFIRMED, 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 REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES MITEK 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. UDI: (B)(4).

    Description of Event or Problem · 0

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP FROM CHINA THAT BEFORE AN UNKNOWN SURGERY, IT WAS DISCOVERED THAT THE PACKAGING WAS OPENED, AND IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINE BR DS W/ORTHCRD DEVICE HAD BROKEN OFF. IT WAS FURTHER REPORTED THAT THREE OTHERS WERE OPENED, AND THEY HAD THE SAME ISSUE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052261 LUPINE BR DS W/ORTHCRD FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 8L25420 10886705001101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown