BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9-POLE SPRING ARM, AC 2000, 15-21 KG

    MDR report key: 2271990 · Received September 28, 2011

    Report

    Report Number
    2031963-2011-00085
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(4) 2011. (B)(4). EVALUATION SUMMARY: WHILE ON SITE FOR A SEPARATE REASON, AN INSTALLATION TECHNICIAN IDENTIFIED A MISSING M3 SCREW ON A SPRING ARM. THE ROOT CAUSE OF THE MISSING M3 SCREW IS UNKNOWN AT THE TIME OF THIS REPORT. IN THIS PARTICULAR CIRCUMSTANCE, THE TECHNICIAN REINSTALLED AN M3 SCREW, AND VERIFIED SCREW WAS SECURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS MALFUNCTION, BUT THERE IS A POTENTIAL FOR EQUIPMENT TO FALL WHEN THE M3 SCREW IS NOT IN PLACE. THIS NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE M3 SCREW WAS MISSING ON A SPRING ARM. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9-POLE SPRING ARM, AC 2000, 15-21 KG BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA