BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 7445704 · Received April 19, 2018

    Report

    Report Number
    2210968-2018-72198
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 21, 2018
    Report Date
    March 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE NEEDLE PULL OFF FROM SUTURE THREAD OR NEEDLE BROKE? VERIFY IF THE ISSUE OCCURRED DURING USE ON PATIENT? IF NO, EXPLAIN. DID THE NEEDLE OR NEEDLE PIECE(S) FALL IN PATIENT'S BODY? WAS IT REMOVED SUCCESSFULLY? SAME PROCEDURE? ANY ADDITIONAL TISSUE DISSECTION/DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE/NEEDLE PIECE(S)? ANY OTHER PATIENT CONSEQUENCES? IF YES, WHAT MEDICAL/SURGICAL INTERVENTION WAS PROVIDED. HOW WAS CASE COMPLETED?

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ONE OPENED COMPLAINT SAMPLE FOIL PACK ALONG WITH SBF FOLDER, NEEDLE AND SUTURE FOR PRODUCT WAS RETURNED FOR ANALYSIS. THE SUTURE PACKS WERE VISUALLY INSPECTED TO CHECK WITH MENTIONED VOC NEEDLE BREAKAGE, BUT NEEDLE BREAKAGE WAS NOT EVIDENT. AS THE COMPLAINT SAMPLE RECEIVED IN OPEN CONDITION FURTHER INVESTIGATION ON COMPLAINT SAMPLE CANNOT BE PERFORMED EXCEPT VISUAL INSPECTION. THE FOIL PACK WAS VISUALLY INSPECTED UNDER MAGNIFICATION FOR ANY DAMAGE AND SHOWED MULTIPLE WRINKLES OVER THE WHOLE FOIL ALONG WITH SEVERAL PINHOLES AT THE TOP LABEL SIDE AS WELL AS ON BOTTOM CAVITY SIDE OF THE PACKS. RETURNED NEEDLE WAS INSPECTED WITH MAGNIFICATION AND NO DEFECT WAS OBSERVED. FIVE RETAIN SAMPLES OF INCIDENT CODES AND LOT NUMBER WAS RETRIEVED FOR ANALYSIS. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTABLE DEFECTS, BUT NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR VISUAL INSPECTION AS WELL AS DESCRIPTION TEST AND FOUND TO MEET THE SPECIFICATION REQUIREMENT. AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED. THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. FINISHED GOOD RECORD WAS REVIEWED FOR TENSILE STRENGTH VALUE AND NEEDLE PULL-OFF VALUE AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE ABOVE ANALYSIS, IT IS EVIDENT THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. THE NEEDLES WERE SUPPLIED BY JOHNSON & JOHNSON MEDICAL (B)(4). HENCE JOHNSON & JOHNSON MEDICAL (B)(4) WAS ALSO INVOLVED INTO INVESTIGATION. THE DHR & COA REVIEW INDICATES THAT ALL RECORDS WERE WITHIN SPECIFICATIONS. ALL ACTIVITIES AND QUALITY INSPECTIONS WERE FOUND ACCORDING TO SPECIFICATIONS. NO ANOMALIES DURING THE PROCESSING OF THE BATCH RELATED TO THE EVENT THAT COULD CAUSE PRODUCT FAILURE WAS IDENTIFIED. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT.

    Additional Manufacturer Narrative · 1

    DID THE NEEDLE PULL OFF FROM SUTURE THREAD OR NEEDLE BROKE? :- NO BREAKAGE NEEDLE VERIFY IF THE ISSUE OCCURRED DURING USE ON PATIENT? IF NO, EXPLAIN. :- NO DID THE NEEDLE OR NEEDLE PIECE(S) FALL IN PATIENT'S BODY? NO WAS IT REMOVED SUCCESSFULLY? SAME PROCEDURE? :- YES ANY ADDITIONAL TISSUE DISSECTION/DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE/NEEDLE PIECE(S)? :- NO ANY OTHER PATIENT CONSEQUENCES? IF YES, WHAT MEDICAL/SURGICAL INTERVENTION WAS PROVIDED. :-NO HOW WAS CASE COMPLETED? :- USED ANOTHER SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BONE SURGERY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286691 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE GAM ETHICON INC. T5002

    Patients

    Seq Age Sex Outcome Treatment
    1