BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER INSTRUMENT

    MDR report key: 11691043 · Received April 19, 2021

    Report

    Report Number
    1644408-2021-00328
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 11, 2021
    Report Date
    October 12, 2021
    Manufacturer
    ENCORE MEDICAL L. P.
    Product Code
    HTW
    UDI-DI
    00888912042710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THIS COMPLAINT WAS A PRIMARY SURGERY REPORTED AS DRILL BIT BROKE. THE HEALTHCARE PROFESSIONAL INDICATED THAT THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK,ADVERSE EVENT, OR NEGATIVE OUTCOME WERE REPORTED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED, WITH A 90-MINUTE DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY AND WAS ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE WHEN THE INCIDENT DRILL BIT BROKE. THE INSTRUMENT WAS NOT RETURNED FOR EXAMINATION AND THE LOT NUMBER WAS NOT REPORTED. WITHOUT THE LOT NUMBER, THE INSTRUMENT COULD NOT BE LINKED TO A SPECIFIC DEVICE HISTORY RECORD AND THE ACTUAL DATE OF MANUFACTURE CANNOT BE DETERMINE WITH CONFIDENCE. AN INVESTIGATION CANNOT BE CONDUCTED. WITHOUT A LOT NUMBER REPORTED, 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 RMA EXAMINATION: THE REPORTED INSTRUMENT WAS NOT RETURNED TO DJO FOR EXAMINATION, THE COMPLAINT FORM INDICATES IT WAS LOST OR DISCARDED. HOWEVER, THE AGENT DID PROVIDE TWO PHOTOS OF THE INSTRUMENT. PHOTOS CONFIRM THE COMPLAINT: THE DRILL HAS BROKEN INTO TWO PIECES, WITH THE BREAK OCCURRING AT THE BASE OF THE CUTTING FLUTES. 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 ITEM BROKE WHILE USING GEN 1 GLENOID DRILL GUIDE. DRILL BROKE AT BASE OF CUTTING FLUTES ~22MM FROM DRILL TOP. NO PIECES LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588567 SHOULDER INSTRUMENT DRILL BIT, 1/8" HTW ENCORE MEDICAL L. P. UNKNOWN 00888912042710

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other