BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE SHOULDER

    MDR report key: 11919120 · Received June 2, 2021

    Report

    Report Number
    1644408-2021-00476
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 10, 2021
    Report Date
    December 21, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    PHX
    UDI-DI
    00888912171564
    PMA / PMN Number
    K141990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS INSTRUMENT FAILURE WAS REPORTED AS BROKEN T-HANDLE. THE POSSIBLE TIME IN SERVICE OF THE MAIN CONTRIBUTOR OF THIS COMPLAINT IS 3 YEARS AND 9 MONTHS FOR TRIAL/IMPLANT INSERTER AND 7 YEARS AND 9 MONTHS FOR T-HANDLE FROM MANUFACTURED DATE. THE HEALTHCARE PROFESSIONAL INDICATED THAT THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK OR ADVERSE EVENT WAS REPORTED. THE SURGERY WAS COMPLETED AS INTENDED, WITH NO DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. THE DEVICES WERE RETURNED TO MANUFACTURER AND EVALUATED BY REGISTERED MEDICAL ASSISTANT (RMA) AT DJO SURGICAL. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORD (DHR) REVEALED THE INSTRUMENT, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMR) ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENTS THAT ARE RELATED TO THE REPORTED ISSUE. COMPLAINT DATABASE REVIEW SHOWS ONE PRIOR COMPLAINT FILED AGAINST ITEM NUMBER 804-03-019 THAT REPORTS A SIMILAR FAILURE. THAT WAS 1 - BROKE/CRACKED/DAMAGED. COMPLAINT DATABASE REVIEW SHOWS TEN PRIOR COMPLAINTS FILED AGAINST ITEM NUMBER 804-06-056 THAT REPORTS A SIMILAR FAILURE. THOSE ARE 9 - BROKE/CRACKED/DAMAGED AND 1 - OTHERS. NO PRIOR COMPLAINTS REPORT PAST INSTANCES OF THESE INSTRUMENTS BEING AFFECTED BY THIS FAILURE. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED WITH CONFIDENCE AS THE INSTRUMENT WAS LOST BEFORE INVESTIGATIONAL REVIEW. IT IS LIKELY ATTRIBUTABLE TO DAMAGE INCURRED FROM PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION, OR ISSUE. THERE ARE NO INDICATIONS THAT THIS INSTRUMENT HAS A SYSTEMIC DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. RMA EXAMINATION: THE REPORTED INSTRUMENT WAS RETURNED TO DJO, HOWEVER WAS LOST THROUGHOUT THE PROCESS OF RETURNING THE DEVICE TO QUALITY. NO FURTHER INVESTIGATION CAN BE MADE. THE COMPLAINT WILL BE CLOSED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - QUICK COUPLING T-HANDLE BROKE DURING REMOVAL OF 6.5MM BONE TAP FROM GLENOID. PATIENT HAD EXCEPTIONALLY HARD BONE AND CAUSED THE CONNECTION BETWEEN THE HANDLE" AND THE SHAFT BROKE, CAUSING "HANDLE" TO ROTATE FREELY AROUND CONNECTION TO SHAFT. THREADED IMPACTION HANDLE KNOB BROKE BETWEEN PROXIMAL AND DISTAL SCREWS DURING IMPLANT INSERTION. DISTAL PORTION OF THREADS ARE STUCK IN FINAL IMPLANT STEM. BREAK HAD NO EFFECT ON MATING BETWEEN POLY INSERT AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822763 ENCORE SHOULDER ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD PHX ENCORE MEDICAL LP 804-06-056 240084L02 00888912171564

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other 804-03-019 LOT 115325L07