BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRING ARM, LIGHT 12-18KG

    MDR report key: 1620530 · Received February 5, 2010

    Report

    Report Number
    2031963-2009-00058
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    August 3, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION (B) (4).

    Description of Event or Problem · 1

    SERIOUS INJURY. THE CUSTOMER REPORTED VIA THE SALES REP THAT DURING THE PROCEDURE WHERE THE PT WAS UNDER LOCAL ANAESTHETIC, THE LIGHT HEAD DETACHED FROM THE SPRING ARM AND FELL ON TO THE PT. IT WAS FURTHER REPORTED THAT THE LIGHT HEAD FELL ON TO THE SHOULDER REGION AND POSSIBLY THE SIDE OF THE FACE OF THE PT. IT WAS FURTHER REPORTED THAT THE PT WAS X-RAYED IN THE THEATRE. WE ARE AWAITING FURTHER DETAILS. ON (B) (6) 2007 THE LIGHT HEAD DETAILS ARE: PRODUCT CODE - 0682000106, (B) (4). IT WAS FURTHER REPORTED THAT ONLY THE PT'S SHOULDER WAS STRUCK BY THE LIGHT AND XRAYS REVEALED NO FRACTURES. IT WAS FURTHER REPORTED THAT THE (B) (6) FEMALE PT WAS KEPT IN OVER NIGHT FOR OBSERVATION. IT WAS FURTHER REPORTED THAT THE PT HAD RECENTLY BROKEN THE SHOULDER THAT THE LIGHT FELL ON TO AND WAS ALREADY EXPERIENCING PAIN PRIOR TO THE EVENT. THE STRYKER ENGINEER REPORTED THAT THE SCREW ATTACHING THE LIGHT HAD SOME HOW WORKED LOOSE ALLOWING THE COLLAR TO MOVE AND THE HORSESHOE ATTACHMENT TO MOVE OUT OF PLACE, ALLOWING THE LIGHT TO DETACH. THE ENGINEER FURTHER REPORTED THAT THE SCREW COULD NOT BE FOUND IN THE THEATRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRING ARM, LIGHT 12-18KG BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other