BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL, EMPOWR ACETABULAR, CANNULATED CUP IMPACTOR

    MDR report key: 17205811 · Received June 26, 2023

    Report

    Report Number
    1644408-2023-00826
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    May 31, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    LXH
    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 (THE CUSTOM CUP IMPACTOR ((S-201494) BROKE WHEN IMPACTING THE CUP. IT BROKE ON THE SHAFT NEAR THE WIND OPENING CLOSEST TO THE HANDLE. THIS IS THE 3RD CUP IMPACTOR THAT HAS BROKE FOR US AND THEY HAVE ALL BROKE AT THIS PORTION OF IMPACTOR. WE NEED TO LOOK DEEPER AT THIS FEMALE, 67) THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RESPONSE WAS RECEIVED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED, WITH NO 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 NOT ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. RMA EXAMINATION: THE INSTRUMENT WAS RETURNED TO DJO AND AFTER FURTHER EXAMINATION, THE SHAFT BROKE NEAR THE HANDLE. THE REVISION LEVEL OR LOT NUMBER WERE 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 4 PREVIOUS COMPLAINTS, BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. S303- BROKE/CRACKED/DAMAGED,4 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.

    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.

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - PART LEFT IN PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221559 SPECIAL, EMPOWR ACETABULAR, CANNULATED CUP IMPACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ENCORE MEDICAL L.P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other