BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL STEM PIN PUNCH

    MDR report key: 17426792 · Received July 31, 2023

    Report

    Report Number
    1818910-2023-15618
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    January 6, 2023
    Report Date
    July 31, 2023
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    MBF
    UDI-DI
    10603295539315
    PMA / PMN Number
    K202716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE REPORTED ALLEGATION. THE TWO HUMERAL PUNCH PINS BROKEN OFF FROM THE REST OF THE DEVICE, ONLY ONE FRAGMENT WAS RETURNED FOR EXAMINATION. 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), MANUFACTURING IRREGULARITIES.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # :(B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INHANCE HEAD TRIAL ADAPTER PIECE BROKE DURING TRIALING. IT BROKE WHILE TRYING TO EXTRACT IT WITH THE INHANCE TUNNING FORK INSTRUMENT. THE DEFICIENCY WAS NOTED BY THE SURGEON THAT THE PIECE SHOULD NOT BREAK THAT EASILY DURING EXTRACTION FROM THE BLAZER AND HEAD TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621936 HUMERAL STEM PIN PUNCH SHOULDER INSTRUMENT - PIN PUNCH MBF DEPUY IRELAND - 3015516266 176272 10603295539315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown