BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 1163395 · Received September 10, 2008

    Report

    Report Number
    2210968-2008-00794
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    A975942
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. D4, H4 - THE ACTUAL DEVICE ASSOCIATED WITH THE EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: ADR411, MFG: 04/01/2008, EXP 01/31/2013. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTS THAT A NEEDLE BROKE DURING A STERNAL CLOSURE. THE NEEDLE REPORTEDLY REMAINS EMBEDDED WITHIN THE BONE. THERE ARE NO PLANS TO EXPLANT THE EMBEDDED NEEDLE FRAGMENT. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAQ ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK