BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 2446721 · Received February 10, 2012

    Report

    Report Number
    2210968-2012-00344
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 20, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH DHB222. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-00341- 2210968-2012-00345. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PIECES OF SUTURE WITH AND WITHOUT KNOTS WERE RETURNED FOR EVALUATION. THEY WERE MICROSCOPICALLY EVALUATED AND BREAKAGES WERE NOTED. THE AMOUNT OF FORCE REQUIRED TO CAUSE THE BREAKAGES COULD NOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE SURGEON OPINES THAT THE FACTORS CONTRIBUTING TO THE BREAKAGE WERE THAT THE DIAMETER OF THE WIRE WAS TOO THIN FOR THIS SURGERY AND THE SURGEON'S TECHNIQUE FOR TYING WIRES. DIFFERENT WIRES, A BAND AND PINS WERE USED DURING THE RE-OPERATION. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. TWO WIRES WERE USED AT THE MANUBRIUM OF THE STERNUM AND FOUR WIRES WERE USED AT THE STERNUM WITH KNOTTED SUTURING TECHNIQUE. AT THAT TIME, THE SURGEON HAD RECOGNIZED THE WIRE AT THE BOTTOM WAS TWISTED. ON (B)(6) 2012, THE PATIENT COMPLAINED OF PAIN IN THE BREAST. ON (B)(6) 2012, THE PATIENT UNDERWENT A CT SCAN. A WIRE WAS BROKEN. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2012 TO REPAIR THE STERNUM. THE SURGEON OPINES THAT THE CAUSE OF THE BREAKAGE WAS THE CLENCHING TECHNIQUE AND THAT THE WIRES WERE THIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention