BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMSYS FEM BROACH SIZE 6

    MDR report key: 17754786 · Received September 15, 2023

    Report

    Report Number
    1818910-2023-18837
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    September 9, 2023
    Report Date
    September 15, 2023
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    QBO
    UDI-DI
    10603295513742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY IT WAS REPORTED THAT THE BROACH AND TRIAL NECK WERE VERY HARD TO DISASSOCIATE. THE NECK AND BROACH APPEAR HAVE SOME BURRING ON THEM. THERE WAS NO SURGICAL DELAY. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS WITH THE EMSYS FEM BROACH SIZE 6. THE DEVICE AND ITS MATING DEVICE ARRIVED ALREADY DISASSEMBLED. NO DEFECT WAS FOUND ON THE DEVICES THAT COULD ATTRIBUTE TO ASSEMBLING ISSUES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE EMSYS FEM BROACH SIZE 6 AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITIONS. FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE IS ABLE TO ASSEMBLE AND DISASSEMBLE PROPERLY. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE EMSYS FEM BROACH SIZE 6 WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BROACH AND TRIAL NECK WERE VERY HARD TO DISASSOCIATE. THE NECK AND BROACH APPEAR HAVE SOME BURRING ON THEM. THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268588 EMSYS FEM BROACH SIZE 6 HIP INSTRUMENT - BROACH QBO DEPUY IRELAND - 3015516266 SO205538 10603295513742

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown