BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER PROSTHESIS INSTRUMENT

    MDR report key: 11084111 · Received December 28, 2020

    Report

    Report Number
    1644408-2020-01263
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    October 9, 2020
    Report Date
    August 5, 2021
    Manufacturer
    ENCORE MEDICAL L. P.
    Product Code
    HTO
    UDI-DI
    00888912148764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SEE B.2., D.9., E.1., G.1. & H.3. MANUFACTURER NARRATIVE: THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS REAMER BLUNT. DISABILITY OR PERMANENT DAMAGE WAS REPORTED. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS A DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS NOT AVAILABLE FOR USE. THE SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS RETURNED TO MANUFACTURER AND DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN AT DJO SURGICAL FOR EXAMINATION. THE REVISION LEVEL OR LOT NUMBER WAS NOT REPORTED, THEREFORE THIS INSTRUMENT COULD NOT BE LINKED TO A SPECIFIC DEVICE HISTORY RECORD (DHR) OR THE ACTUAL DATE OF MANUFACTURE COULD NOT BE DETERMINED WITH CONFIDENCE. COMPLAINT DATABASE REVIEW SHOWED PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. SUMMARY OF COMPLAINTS: 100-FUNCTIONAL 1 & 102-DULL/WORN 1. THE EVENT IS ATTRIBUTABLE TO THE SURGEON NOT INSPECTING THE PRODUCT PRIOR TO SURGERY. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION OR ISSUE. NO FURTHER EVALUATION CAN BE MADE FOR THIS EVENT. THIS CUSTOMER COMPLAINT WILL BE CLOSED. IF THE DEVICE IS RETURNED LATER, THE COMPLAINT WILL BE UPDATED. THERE ARE NO INDICATIONS THAT THESE INSTRUMENTS HAVE A DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. 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 AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - DUE TO 1/2 MOON REAMER BLUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539309 REVERSE SHOULDER PROSTHESIS INSTRUMENT RSP GLENOID HALF-MOON REAMER, SMALL HTO ENCORE MEDICAL L. P. UNKNOWN 00888912148764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S