BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE

    MDR report key: 16839057 · Received April 28, 2023

    Report

    Report Number
    1644408-2023-00511
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    April 5, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HE AGENT REPORTED (IT BROKE IN THE GLENOID BASEPLATE, THAT WAS IN THE PATIENT.). THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. SIGNIFICANT ADVERSE EVENT WAS REPORTED 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 ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. RMA EXAMINATION: THE INSTRUMENT WAS RETURNED TO DJO AND AFTER FURTHER EXAMINATION, THE GLENOID BASEPLATE SCREW IS STUCK IN A SLANT POSITION. A REVIEW OF S-201106 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 7 PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. S303 - BROKE/CRACKED/DAMAGED, 7. THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY DUE TO FORCEFUL USE AND NOT ALIGNING THE THREADS OF THE SCREW WITH THE GUIDE CAUSING THE SCREW TO BECOME STUCK. 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

    REVISION SURGERY - DUE TO INSTRUMENT BROKE IN THE GLENOID BASEPLATE, THAT WAS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565890 SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ENCORE MEDICAL L.P 358025L03

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other