BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, -4MM

    MDR report key: 17122120 · Received June 13, 2023

    Report

    Report Number
    1644408-2023-00786
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    March 11, 2022
    Report Date
    June 13, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    PHX
    UDI-DI
    00888912024778
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED "(DURING SURGERY AT THE TIME OF PLACING THE CENTRAL SCREW THAT FIXES THE GLENOID HEAD 36 -4 TO THE BASEPLATE, THE SCREW NEVER LOCKS AND KEEPS TURNING AND TURNING. THE HEAD IS REMOVED AND THE SCREW IS PLACED IN THE GLENOID BASE AND THE SCREW IS FIXED TO THE BASE THE EDGES ARE REGULARIZED AND THE HEAD IS PLACED AGAIN AND IT RETURNS AND THE SAME THING HAPPENS, AT THE TIME OF FIXING THE SCREW NEVER LOCKS, WHICH IS WHY ANOTHER HEAD IS OPENED AND REMAINS FIZZED.)." THE HEAD AND SCREW WERE MARKED AS LOST OR DISCARDED, SEE PRODUCT FEEDBACK FORM SEC. D-5, THEREFORE THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THIS EVENT OCCURRED DURING THE PRIMARY SURGERY NEAR THE PATIENT. THE COMPONENTS WERE INSPECTED PRIOR TO USE. THERE WAS ANOTHER SUITABLE DEVICE AVAILABLE, HOWEVER, THE INCIDENT DID CAUSE A DELAY IN SURGERY. THE LENGTH OF THE DELAY WAS NOT NOTED. THERE WAS NO RISK OR ADVERSE EVENT REPORTED AND THE SURGERY WAS COMPLETED AS INTENDED. SURGICAL COMPONENTS CONDITION CAN BE DETERMINED WHILE BEING USED FOR ITS INTENDED PURPOSE. THIS DOES NOT INDICATE A PRODUCT DEFICIENCY, FAILURE, OR ISSUE. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THE GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, -4MM, WHEN RELEASED FOR USE ON (B)(6)2020, 15 PARTS, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME IT WAS USED. REVIEW OF THE PICK LIST REPORT SHOWS THE (50800001-10) SCREW, RETAINING GLENOID HEAD RSP, PICKED 15 OUT OF 1190 PARTS ON (B)(6)20. RECEIVER(S) (ATTACHED) REVIEW FOR THE RETAINING SCREW: RC NO. 200793: SHOWS NCMR #57186 (B)(6)20) FOR MISSING SUPPLIER PAPERWORK, DISPOSITION REWORK, SUPPLIER SENT IN PAPERWORK, 316 PARTS ACCEPTED. RC NO. 183893: SHOWS 280 PARTS ACCEPTED (B)(6)20). RC NO. 177846: SHOWS NCMR #52677 (B)(6)19) FOR MISSING SUPPLIER PAPERWORK. DISPOSITION REWORK, SUPPLIER SENT IN PAPERWORK, 2000 PARTS ACCEPTED. COMPLAINT HISTORY: TO DATE, CUSTOMER COMPLAINT HISTORY OF THE REPORTED INCIDENT SHOWED 4 PREVIOUS COMPLAINTS: (B)(4). THIS IS THE 3RD COMPLAINT AGAINST LOT NUMBER 871C1281 ACROSS ALL FAILURE CODE CATEGORIES AND THE FIRST WITH THIS INCIDENT. THERE ARE NO INDICATIONS THAT THIS ITEM HAS A DESIGN OR MATERIAL DEFICIENCY. THE ROOT CAUSE FOR THIS COMPLAINT IS THAT THE SCREW NEVER LOCKS AND KEEPS TURNING AND TURNING. BECAUSE NO COMPONENTS WERE RETURNED WITH THIS COMPLAINT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SEVERAL FACTORS COULD CONTRIBUTE TO A RETAINING SCREW NOT ENGAGING, LIKE, DAMAGED INTERNAL THREADS IN THE BASEPLATE, DAMAGED EXTERNAL THREADS ON THE RETAINING SCREW, IMPROPER ALIGNMENT OR CROSS THREADING OR DEBRIS IMPINGING ON OR NEAR THE THREADS.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS AT LEAST A 20 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408797 GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, -4MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ENCORE MEDICAL L.P 508-36-103 871C1281 00888912024778

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other