BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET DOUBLE CLAMP BAR

    MDR report key: 1475797 · Received June 12, 2009

    Report

    Report Number
    1035617-2009-00008
    Event Type
    Malfunction
    Date Received
    June 12, 2009
    Date of Event
    February 1, 2006
    Report Date
    February 21, 2006
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    HST
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SINGLE CLAMP BAR, PRODUCT CODE 00-0640-007-00 AND TWO OFFSET DOUBLE CLAMP BARS, PRODUCT CODE 00-1066-005-00 WERE RETURNED FOR EVALUATION. HOWEVER, IT COULD NOT BE DETERMINED IF THE DEVICES WERE ASSOCIATED WITH THE EVENT REPORTED IN THIS MEDWATCH. VISUAL EXAMINATION REVEALED THAT THE 48" PLAIN BAR CLAMP WAS BROKEN AT THE BASE AND THE SECOND WAS BROKEN AT THE HINGE. THIS MDR IS BEING SUBMITTED LATE, AS IT WAS IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW CONDUCTED BY ZIMMER ORTHOPEDIC SURGICAL PRODUCTS (ZIMMER OSP). THIS RETROSPECTIVE REVIEW WAS CONDUCTED IN RESPONSE TO AN INSPECTIONAL OBSERVATION AT A ZIMMER FACILITY. THE AGENCY'S INSPECTIONAL OBSERVATION CONCERNED THE COMPANY'S DECISION(S) NOT TO SUBMIT CERTAIN MDRS FOR PRODUCTS SPECIFIC TO THAT ZIMMER FACILITY. WHILE A RETROSPECTIVE REVIEW OF COMPLAINTS FOR UNREPORTED MDRS WAS CONDUCTED IMMEDIATELY FOLLOWING THE INSPECTION AT THE FACILITY, ZIMMER DETERMINED THAT SUCH A REVIEW WOULD BE CONDUCTED AT ALL ZIMMER FACILITIES. AS A RESULT, ZIMMER OSP COMPLETED ITS RETROSPECTIVE REVIEW AND IS NOW SUBMITTING THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLAMP BROKE AND THE TRAPEZE UNIT FELL, STRIKING THE SIDE OF THE PT'S HEAD. IT WAS REPORTED THAT THE PT EXPERIENCED HEADACHES. THERE WAS NO MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT. NO FURTHER INJURY OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFSET DOUBLE CLAMP BAR OFFSET DOUBLE CLAMP BAR HST ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1