BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 20013045 · Received August 21, 2024

    Report

    Report Number
    1644408-2024-01270
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 24, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    HTO
    UDI-DI
    00190446729181
    PMA / PMN Number
    E529270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE D3, D4 EXPIRATION DATE, G1, H6, H10 AND H11. THE AGENT REPORTED "AP REAMER MADE SLIGHT INTERFERENCE WITH THE HALF WEDGE REAMING GUIDE. SURGEON WAS NOT COMFORTABLE MOVING FORWARD. PREFERRED A SHOULDER REVERSE ARTHROPLASTY INSTEAD. SURGEON WAS UNSURE IF HE PUSHED TO HARD ON THE REAMER. SLIGHT DAMAGE ON INSTRUMENTS." THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK OR ADVERSE EVENT WAS REPORTED BY THE SURGEON. THERE WAS A 20 MINUTE DELAY IN SURGERY, BUT THE SURGERY WAS COMPLETED AS INTENDED. THE INSTRUMENTS WERE INSPECTED PRIOR TO USE AND WERE FOUND TO BE ACCEPTABLE. THE AGENT WAS PRESENT WHEN THIS EVENT OCCURRED AND WAS ABLE TO PROVIDE ANOTHER SUITABLE DEVICE. RMA EXAMINATION: THE REPORTED DEVICE WAS RETURNED TO SURGICAL FOR EVALUATION. THERE IS SLIGHT WEAR ON THE DEVICE (SEE IMAGES). UNABLE TO RECREATE THE REPORTED FAILURE UNDER POWER AND MANUALLY. THERE IS NO CLEAR INTERFERENCE OCCURRING. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORDS (DHR) REVEALED, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NCMRS ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENT THAT IS RELATED TO THE REPORTED ISSUE. COMPLAINT DATABASE REVIEW SHOWED NO PREVIOUS COMPLAINTS THAT ALLEGE THIS SAME ISSUE. THERE ARE NO INDICATIONS THAT THE INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE AS THE FAILURE COULD NOT BE RECREATED. IT IS POSSIBLE THAT THERE WAS TISSUE OR BONE THAT WAS CAUSING SOME INTERFERENCE. 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 - AP REAMER MADE SLIGHT INTERFERENCE WITH THE HALF WEDGE REAMING GUIDE. SURGEON WAS NOT COMFORTABLE MOVING FORWARD. PREFERRED A SHOULDER REVERSE ARTHROPLASTY INSTEAD. SURGEON WAS UNSURE IF HE PUSHED TO HARD ON THE REAMER. SLIGHT DAMAGE ON INSTRUMENTS, 20 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350321 DJO SURGICAL ALTIVATE ANATOMIC AG, GLENOID REAMER AP, SZ 50 HTO ENCORE MEDICAL L.P. 10368020L03 00190446729181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other 804-09-027 LOT: 10395803L03