MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 54"(135CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J531H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device codes: (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.What is the lot number? how was the suture placed (interrupted or continuous)? which tissue layer, at which location was the suture, was used to close? did the suture absorb prior to or beyond the appropriate time frame? what was the surgeons expected time between the suture placement and the "absorption"? did the operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient? was the suture package reprocessed or sterilized? was the package noted to be damaged? the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown procedure (b)(6) 2018, and a suture was used.The vicryl suture didn't absorb in an appropriate time frame.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/28/2018.Investigation summary: it was reported absorption of suture.An unopened sample of product code j531 lot mbz730 was returned for analysis.During the visual inspection of the representative sample, was examined for visual defects: appearance, color packages, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured).The packet was opened and during the visual inspection, the swage and attachment area were as expected, the suture strand was correctly placed on the tray and dispensed without problems.No defects or damaged were observed along of suture.In addition, the vicryl suture retains approximately 75 % of the original tensile strength two weeks post implantation.At three weeks, approximately 50% and the absorption total of vicryl suture is essentially complete between 56 and 70 days.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative sample, no defects were found.Additional information was requested and the following was obtained: how was the suture placed (interrupted or continuous)? unsure, as i didn¿t do the repairs.I did remove knots from each of the patients and then long strands of suture material.Therefore i¿d assume it was a continuous stitch.Which tissue layer, at which location was the suture, was used to close? all of these patients had 2nd degree tears (muscle layers) and one had an episiotomy (also a muscle layer).Did the suture absorb prior to or beyond the appropriate time frame? the suture material that could not be removed, as far as i can tell, was absorbed in the appropriate time frame.However, in one case we could not get access to the knot, we could see it below the skin surface, but the skin had healed over it.I¿m not sure if that knot ever dissolved.The problem wasn¿t that it was ¿noticeable¿, it was that these women were in so much pain at 2+ weeks postpartum (after they had stated their perineum was feeling better in the first couple weeks), that i had to inspect the repair and remove the material.I¿m unsure if the material would have absorbed had it been left in.I also would not have kept the material in to find out, as these women were in so much pain and had discomfort.What was the surgeons expected time between the suture placement and the "absorption¿? i tell all my patients it takes 55 - 70 days to dissolve and not be seen, however the repair should feel better and better each day and by 2 weeks she should have little to no discomfort.In these cases, by 2 weeks their perineum and vagina were extremely painful.Did the operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient? i did not do the repair, so i¿m unsure of any deficiency or anomaly.Was the suture package reprocessed or sterilized? all our sutures come from the manufacturer, the packaging was not reprocessed was the package noted to be damaged? i did not do the repair, but i¿d assume it wouldn¿t be used if there was package damage noted.The obstetrician stated he would not use a package that was damaged.

• Brand Name: VICRYL SUTURE 54"(135CM) 3-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8002491
• Report Number: 2210968-2018-76713
• Device Sequence Number: 16193831
• Product Code: GAM
• UDI-Device Identifier: 10705031040960
• UDI-Public: 10705031040960
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: J531H
• Device Lot Number: MBZ730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/28/2018
• Patient Sequence Number: 1