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

Catalog Number Y732H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

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.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 Description

It was reported that an animal underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the suture detached from the needle.Another like device was used to complete the procedure.There were no adverse consequences for the animal.No additional information was provided.

Manufacturer Narrative

(b)(4).A labeled winding former with an un-dispensed suture and a detached needle of product code y732 were returned for analysis.During the visual inspection of the needle, the swage and attachment area were as expected.The barrel hole was examined under 20x magnification for suture remnant and none was noted.The suture end was examined and there isn¿t sufficient impression at the swage end, resulting in the needle pull off.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause is a light swage defect.

• Brand Name: MCRYL VIO 36IN 2-0 S/A SH
• 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: 7634095
• MDR Text Key: 112185872
• Report Number: 2210968-2018-73727
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059528
• UDI-Public: 10705031059528
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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: 03/31/2022
• Device Catalogue Number: Y732H
• Device Lot Number: LDK040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1