BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM DI INTERMEDIATE TIGHTENER

    MDR report key: 2822399 · Received November 7, 2012

    Report

    Report Number
    1526439-2012-00253
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    April 26, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES SPINE HAS REQUESTED RETURN OF THE TIGHTENER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE INSTRUMENT AND COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INTERMEDIATE TIGHTENER CONFIRMED TIP BREAKAGE. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO DEFINITIVE CONCLUSIONS CAN BE MADE AT THIS TIME. HOWEVER, TIP BREAKAGE APPEARS TO BE RELATED TO FORCES APPLIED TO THE INSTRUMENT DURING USAGE. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE ROOT CAUSE AND/OR CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT EXAMINATION OF THE INTERMEDIATE TIGHTENER FOUND THE TIP HAD BROKEN OFF FROM THE INSTRUMENT. THE BROKEN TIP SECTION WAS NOT RETURNED. THE INSTRUMENT WAS CONTAINED IN A RETURNED LOANER KIT. IT IS NOT KNOWN WHEN/WHERE THE BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM DI INTERMEDIATE TIGHTENER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM 0809NT

    Patients

    Seq Age Sex Outcome Treatment
    1