BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY ELBOW

    MDR report key: 15001925 · Received July 13, 2022

    Report

    Report Number
    1644408-2022-00870
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 24, 2022
    Report Date
    July 29, 2022
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS INSTRUMENT FAILURE WAS REPORTED AS BROKEN GROOVE TAB. THE POSSIBLE TIME IN SERVICE OF THE MAIN CONTRIBUTOR OF THIS COMPLAINT IS 1.4 YEARS FROM MANUFACTURED DATE. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NOT ANOTHER SUITABLE DEVICE AVAILABLE, CAUSING A 60 MIN. DELAY IN SURGERY, HOWEVER, THE SURGERY WAS COMPLETED AS INTENDED. THE INSTRUMENT WAS INSPECTED PRIOR TO SURGERY AND WAS FOUND TO BE ACCEPTABLE. THE DEVICE WAS NOT RETURNED TO MANUFACTURER AND NOT MADE AVAILABLE FOR REGISTERED MEDICAL ASSISTANT (RMA) DJO SURGICAL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED, WHEN RELEASED FOR USE, THE ITEM MET DESIGN AND MANUFACTURING REQUIREMENTS. COMPLAINT DATABASE REVIEW SHOWED PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THOSE ARE 5 BROKE/CRACKED/DAMAGED. THE ROOT CAUSE OF THIS COMPLAINT IS ATTRIBUTABLE TO DAMAGE INCURRED THROUGH ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION OR ISSUE. SURGICAL INSTRUMENTS CONDITION CAN BE DETERMINED WHILE BEING USED FOR ITS INTENDED PURPOSE. THE REPLACEMENT OF SURGICAL INSTRUMENTS DUE TO NORMAL WEAR AND TEAR DOES NOT INDICATE A PRODUCT DEFICIENCY, FAILURE OR ISSUE. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THERE ARE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY THEREFORE NO CONTAINMENT OF INVENTORY IS REQUIRED. EXAMINATION CONFIRMED THE COMPLAINT, THE RETURNED INSTRUMENT SHOWS ONE TAB BROKEN OFF (PIECE NOT RETURNED). THE REPORTED CONDITION COULD POSSIBLY BE A RESULT OF HEAVY USE, MISUSE, WEAR, AND CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - SURGEON WHILE PERFORMING A BEARING REVISION, BROKE THE PIN GROOVE TAB ON THE BEARING ROTATIONAL TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670141 DISCOVERY ELBOW DISC BEARING ROTATION TOOL HWT ENCORE MEDICAL L.P. 334491L05

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other