BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE

    MDR report key: 3894791 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08207
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL DEVICE WAS RETURNED FOR EVALUATION. MICROSCOPIC VISUAL EXAMINATION ON NEEDLE THAT WAS BROKEN AT THE ATTACHMENT END REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY A 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." ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. TWO POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: BATCH HB2422, BATCH HC2025. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER HB2422, WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN THE SURGEON WAS MAKING A KNOTTED SUTURE THROUGH THE DERMIS. THE SURGEON OPINED THAT THE NEEDLE MIGHT HAVE BROKE DUE TO EXTRA FORCE APPLIED TO IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370281 PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE NEW ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1