BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIS BROACH SIZE 8

    MDR report key: 19992480 · Received August 15, 2024

    Report

    Report Number
    1818910-2024-17503
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 15, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    QBO
    UDI-DI
    10603295548676
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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 RECORDS EVALUATION (MRE) WAS NOT PERFORMED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE MALFUNCTION, VISUAL: STRIPPED/TWISTED/CROSS THREADED, WILL NO LONGER BE REPORTED AS THERE HAS NOT BEEN A SERIOUS INJURY ASSOCIATED WITH THIS FAILURE WITHIN THE PAST 2 YEARS. PLEASE CONSIDER THIS THE LAST MANUFACTURER REPORT NUMBER SUBMITTED AGAINST THIS MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRUNNION IS WORN, WILL NOT CONNECT TO KINCISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163498 ACTIS BROACH SIZE 8 HIP INSTRUMENT - BROACH QBO DEPUY IRELAND - 3015516266 PG334699 10603295548676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown