BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL GLENOID - CENTRAL SCREW 20MM

    MDR report key: 10884304 · Received November 23, 2020

    Report

    Report Number
    1220246-2020-02358
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 23, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057937
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A (B)(6) 2020 REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE FOLLOWING ISSUES OCCURRED WITH TWO ARTHREX INSTRUMENTS: INSTRUMENT 1: THE MEDIUM T-15 DRIVER (AR-9545-T15-02 #8001928) HAS BEEN COMPROMISED. WHEN TRYING TO EXTRACT THE CENTRAL SCREW FROM A UNIVERSAL GLENOID, THE TIP OF THE DRIVER BECAME TWISTED AND A SMALL PIECE BROKE OFF INTO THE HEAD OF THE CENTRAL SCREW. THERE WAS A 5 MINUTE DELAY IN SURGERY AS THE SCREW HEAD COULD NO LONGER BE ACCESSED. THE SURGEON USED OSTEOTOMES AROUND THE PERIPHERY OF THE BASEPLATE TO EVENTUALLY EXTRACT THE BASEPLATE AND CENTRAL SCREW AS ONE PIECE. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED, BUT THE SMALLER PIECE WAS LODGED INTO THE CENTRAL SCREW IMPLANT WHICH WAS NOT AVAILABLE FOR RETURN. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. INSTRUMENT 2: THE TRINITY BASEPLATE IMPACTOR (AR-9165CDG #(10)051917) HAS BEEN COMPROMISED. THE SURGEON ENGAGED THE ALREADY IMPLANTED BASEPLATE WITH THE IMPACTOR SO THAT IMPACTION MIGHT DISRUPT THE BONY BOND WITH THE BASEPLATE. AFTER IMPACTION, IT WAS NOTICED THE BLUE PLASTIC PORTION OF THE IMPACTOR HAD BECOME BENT AND A SMALL PLASTIC PIECE HAD BROKEN OFF. THERE WAS NO DELAY IN SURGERY AS THE SURGEON HAD USED THE INSTRUMENT AS DESIRED. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED INTRA-OPERATIVELY, BUT THE SMALL PLASTIC PIECE WAS LOST DURING CLEANING POST-SURGERY. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. ADDITIONAL INFORMATION OBTAINED 11/2/20: THE PATIENT'S ORIGINAL SURGERY HAD TAKEN PLACE (B)(6) 2013. THE PATIENT WAS EXPERIENCING PAIN AND AN INFECTION WAS SUSPECTED. THE PATIENT UNDERWENT THE (B)(6) 2020 SECOND SURGERY AND ALL OF THE ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED. THE CASE WAS COMPLETED BY IMPLANTING AN EXACTECH INTERSPACE SPACER. HOSPITAL POLICY PREVENTS RELEASE OF THE DEVICES TO RETURN TO THE MANUFACTURER FOR EVALUATION. THE FOLLOWING ARE THE ORIGINAL SURGERY IMPLANTS THAT WERE EXPLANTED (B)(6) 2020: AR-7219, LOT 05380. AR-9120-01, LOT 2501239905. AR-9145-30, LOT 2501238403. AR-9145-36, LOT 2501239003. AR-9165-20, LOT 2501239403. AR-9501-09RCPC, LOT 2501237205. AR-9502-42LCPC , LOT 2501246403. AR-9503L-03C, LOT 2501244502. AR-9504L-04, LOT2501212201. AR-9550-12, LOT 2501214601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352498 UNIVERSAL GLENOID - CENTRAL SCREW 20MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERSAL GLENOID - CENTRAL SCREW 20MM 2501239403 00888867057937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other