BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER PROSTHESIS INSTRUMENT

    MDR report key: 11638426 · Received April 8, 2021

    Report

    Report Number
    1644408-2021-00308
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    February 22, 2021
    Report Date
    October 12, 2021
    Manufacturer
    ENCORE MEDICAL L. P.
    Product Code
    HTO
    UDI-DI
    00888912147842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THE INSTRUMENT FAILURE WAS THE TAP SNAPPED OFF INSIDE THE GLENOID. 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, WITHOUT DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY BUT WAS NOT ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE WHEN THE INCIDENT TAP BROKE. THIS INVESTIGATION IS LIMITED IN SCOPE AS ONLY PARTIAL INFORMATION WAS PROVIDED TO DJO SURGICAL FOR REVIEW. THE REVISED ITEMS WERE NOT RETURNED FOR EXAMINATION AND THE LOT NUMBERS WERE NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE LOT NUMBERS ARE NECESSARY. GIVEN THE LIMITED INFORMATION, A SEARCH OF DJO AND AVAILABLE ZIMMER BIOMET RECORDS FOR THE PREVIOUS SURGERY PRODUCED NO RESULTS, THEREFORE; THE ITEMS COULD NOT BE VERIFIED. IF THIS INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. 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. CUSTOMER COMPLAINT HISTORY OF THE REPORTED ITEMS SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON PERFORMED THIS REVISION TO REMEDY THE PATIENT'S CONDITION. THIS COMPLAINT WILL BE CLOSED PENDING RECEIPT OF ADDITIONAL INFORMATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. RMA EXAMINATION: THE REPORTED INSTRUMENT WAS NOT RETURNED TO DJO FOR EXAMINATION. THE COMPLAINT FORM INDICATES IT WAS DISCARDED. 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 DURING THE TAPPING PROCESS, THE TAP SNAPPED OFF INSIDE THE GLENOID. DR. REDIRECTED THE DRILL AND PLACED THE BASEPLATE INFERIOR OF THE BROKEN TAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530358 REVERSE SHOULDER PROSTHESIS INSTRUMENT GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER HTO ENCORE MEDICAL L. P. UNKNOWN 00888912147842

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other