BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL STEM PIN PUNCH

    MDR report key: 17929804 · Received October 13, 2023

    Report

    Report Number
    1818910-2023-20871
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 13, 2023
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    MBF
    UDI-DI
    10603295539315
    PMA / PMN Number
    K202716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED, THAT PUNCH PRONG WAS BROKEN. 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 THE HUMERAL STEM PIN PUNCH HAS ONE OF THE OF THE HUMERAL PUNCH PINS BROKEN. FRAGMENT WAS RETURNED FOR EVALUATION. NO OTHER DEFECTS WERE OBSERVED. THE OVERALL COMPLAINT WAS CONFIRMED. AS THE OBSERVED, CONDITION OF THE HUMERAL STEM PIN PUNCH WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MANUFACTURING. THE PRODUCT ISSUE HAS BEEN ADDRESSED THROUGH DEPUY SYNTHES QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: AN NC SEARCH FOUND, A PREVIOUS NON-CONFORMANCES (NR-0182318) RELATED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: 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). 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 PUNCH PRONG WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683037 HUMERAL STEM PIN PUNCH SHOULDER INSTRUMENT - PIN PUNCH MBF DEPUY IRELAND - 3015516266 176272 10603295539315

    Patients

    Seq Age Sex Outcome Treatment
    1 Female