MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y923H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(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.Additional information was requested and the following was obtained: the original product code provided was (b)(4) with no lot provided, but the original information cites product code (b)(4) and lot lj6971.Did needles detached from the suture with product code (b)(4) and lot lj6971? if not please clarify any other quality issue experienced with product code (b)(4) and lot lj6971.(b)(4) was an error.Product in complaint is only (b)(4).What is the quantity of sutures that experienced the quality issue from product code (b)(4) and lot lj6971? 1 in the complaint and another 14 in the box unopened.Credit will be needed for all.Did the event occur during one or more patient procedures? 1 procedure.If this occurred in more than one patient procedure, have any of those procedures been previously reported to ethicon? if so, please provide the respective reference number(s).What are the procedure name(s) and date(s)? were there any adverse patient consequences? did any piece of the needle fall inside of the patient? no.If so, was the needle piece removed and how? what is the lot number for product code (b)(4)? not applicable.

Event Description

It was reported that an animal underwent a spaying / neutering procedure on (b)(6) 2018 and suture as used.During wound closure, the needle detached from suture after a few passes.There were no adverse patient consequences.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).A labeled winding former with a detached needle stuck on the paper lid, an opened box with unopened samples of product were returned for analysis.During the visual inspection of the needle, the swage and attachment area were as expected and remnant of the suture was noted into the barrel hole and slightly marks were observed on the edge of the needle that appears to be by the use of a surgical instrument were observed and this condition caused that the needle detached from suture.The suture was not received for evaluation.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Functional test was performed on the samples using an instron and the pull force were above the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the samples condition no performance pull off suture needle were found.

• Brand Name: MCRYL VIO 36IN 3-0 S/A FS-2
• 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
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7457064
• MDR Text Key: 106388360
• Report Number: 2210968-2018-72336
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059863
• UDI-Public: 10705031059863
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

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: 07/31/2022
• Device Catalogue Number: Y923H
• Device Lot Number: LJ6971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• 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