MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y936H

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: please specify.Was there any suture needle separation?, suture breakage? or needle breakage? yes.Happened on multiple occasions.Suture broke.In another instance stitch broke not near swag of needle.Product codes and lot numbers: lek109.There also has been additional lots since initial instance.Event date: (b)(6) 2017, procedure name - cabg.Cabg avr.Emergency cabg.Patient consequences/ae report if any? suture broke.Replaced with new suture.If lots were noticed before hand, they were switched out before procedure start.Was procedure completed successfully? yes.Qty involved? 2/case.Sample return, if any? there has been additional suture lots.Lots involved include lek109 and lez383.

Event Description

It was reported that a patient underwent a cabg procedure and suture was used.When the suture was pulled through the skin the needle would pop off or the suture would break.No adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4).A labeled winding former with a needle/suture combination in tray was received for evaluation.During the visual inspection of sample, the swage and attachment area of needle were as expected.Also, suture was dispensed and it has begun with the process of disintegration, since the suture was breakage in several sections.The product code y936 contains an absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The foil was not returned for evaluation to determine if any damaged was present, that could be attributable to degradation of the suture.Per the sample condition the assignable cause of performance pull off suture needle and breakage suture, was caused by suture degradation exposure to environment.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 3-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7263341
• MDR Text Key: 99988637
• Report Number: 2210968-2018-70801
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059917
• UDI-Public: 10705031059917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: Y936H
• Device Lot Number: LEK109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1