BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7 4-18 " STEEL MONO CCS

    MDR report key: 3576687 · Received January 15, 2014

    Report

    Report Number
    2210968-2014-00337
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    December 26, 2013
    Report Date
    December 26, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH ELP501 MFG DATE: 10/01/2012, EXP DATE: 07/31/2017. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL NEEDLE REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILE FAILURE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. THE DEVICE INFORMATION FOR USE CAUTIONS THE USER THAT "TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED ON THE BREASTBONE. THE NEEDLE PASSED INTO THE TISSUE, BUT THE BONE WAS TOO HARD TO PASS THROUGH. THE NEEDLE TIP BROKE AND REMAINS IN THE BREASTBONE. THE SURGEON CLOSED THE WOUND WITHOUT RETRIEVING THE BROKEN PIECE. THE SURGEON OPINES THAT IT WOULD BE TOO DIFFICULT TO RETRIEVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38930 7 4-18 " STEEL MONO CCS SUTURE, NON-ABSORBABLE GAQ ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other