BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO EMPOWR KNEETM, SZ 7, 4-IN-1 CUT BLOCK 2

    MDR report key: 18253049 · Received December 1, 2023

    Report

    Report Number
    1644408-2023-01714
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 7, 2023
    Report Date
    December 1, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    FZX
    UDI-DI
    00190446255796
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED (PEG ON 4:1 SZ 7 BROKE OFF IN PATIENT. FEMALE) THIS EVENT OCCURRED DURING CLEANING AND STERILIZATION, NEAR THE PATIENT. NO RESPONSE WAS RECEIVED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED, WITH A FIVE-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. RMA EVALUATION: THE INSTRUMENT WAS RETURNED TO DJO AND AFTER FURTHER EXAMINATION, ONE OF THE PEGS ON THE SIZER BLOCK BROKE OFF. A REVIEW OF 800-05-087 DEVICE HISTORY RECORD (DHR) REVEALED THE INSTRUMENT, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NCMRS ASSOCIATED WITH THE PRODUCTION OF THIS INSTRUMENT. COMPLAINT DATABASE REVIEW SHOWED NO PREVIOUS COMPLAINTS AND THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. S303- BROKE/CRACKED/DAMAGED THE ROOT CAUSE OF THIS COMPLAINT 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.

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - INSTRUMENT BROKE, PARTS LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504248 DJO EMPOWR KNEETM, SZ 7, 4-IN-1 CUT BLOCK 2 GUIDE, SURGICAL, INSTRUMENT FZX ENCORE MEDICAL L.P 252208L06 00190446255796

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other