BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL STEM PIN PUNCH

    MDR report key: 16247053 · Received January 26, 2023

    Report

    Report Number
    1818910-2023-02053
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 13, 2023
    Report Date
    January 26, 2023
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    MBF
    UDI-DI
    10603295539315
    PMA / PMN Number
    K202716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 SYNTHESE FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE REPORTED ALLEGATION. ONE OF THE OF THE HUMERAL PUNCH PINS BROKE OFF FROM THE REST OF THE DEVICE, FRAGMENT WAS RETURNED FOR EVALUATION. 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.

    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. 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 DURING AN INHANCE REVERSE CASE THERE WERE 2 INSTRUMENTS THAT BROKE. THE FIRST WAS THE ¿DRIVER¿ (6205-10-105). WHILE REAMING THE GLENOID, THE GLENOID REAMER DETACHED FROM THE DRIVER & BROKE THE PLASTIC HOUSING AT THE JUNCTION WHERE THE REAMER ATTACHES TO THE DRIVER. WE HAD CONFIRMED THAT THE REAMER WAS FULLY SEATED INTO THE DRIVER PRIOR TO REAMING. I DON¿T HAVE AN EXPLANATION HOW IT COULD HAVE BROKE THE DRIVER. THE SECOND INSTRUMENT THAT BROKE WAS THE HUMERAL STEM PIN PUNCH (6201-01-121). DURING HUMERAL PREP THE STEM PIN PUNCH WAS ADVANCED THROUGH THE BLAZER TO THE APPROPRIATE DEPTH. AS THE PIN PUNCH WAS BEING REMOVED, ONE OF THE PINS BROKE INSIDE THE HOUSING JUNCTION OF THE HANDLE. THE BROKEN PIN WAS EASILY REMOVED FROM THE HUMERUS THROUGH THE BLAZER WITH A PAIR OF PLIERS. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175195 HUMERAL STEM PIN PUNCH SHOULDER INSTRUMENT - PIN PUNCH MBF DEPUY IRELAND - 3015516266 6201-01-121 176272 10603295539315

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male