BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE

    MDR report key: 17176095 · Received June 21, 2023

    Report

    Report Number
    1644408-2023-00772
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 21, 2023
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED (THE GLENOID 4-HOLE DRILL GUIDE FIXATION SCREW BROKE OFF WHEN FIXING TO THE BASEPLATE. THE BASEPLATE WAS REMOVED AND REPLACED WITH NEW ONE. THE DISTAL THREADS OF THE 4 HOLE GUIDE SCREW ARE IN THE BASEPLATE. AGE-63/GENDER-MALE) THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK OR ADVERSE EVENT WAS REPORTED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED, WITH A 10-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 EXAMINATION: THE INSTRUMENT WAS RETURNED TO DJO AND AFTER FURTHER EXAMINATION, THE BROKE OFF FROM THE GUIDE. DEVICE HISTORY: 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 HISTORY: COMPLAINT DATABASE REVIEW SHOWED 8 PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY ATTRIBUTABLE TO DAMAGE INCURRED FROM MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION, OR ISSUE. CONTAINMENT: THERE ARE NO INDICATIONS THAT THIS INSTRUMENT HAS A SYSTEMIC DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    PRIMARY SURGERY - PART LEFT IN PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061130 SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ENCORE MEDICAL L.P. 334129L01

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other 508-32-104, LOT 866C3141