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

Catalog Number	Y732H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: it was reported needle pull off.A labeled winding former with a partially dispensed suture and a detached needle of product code (b)(6) were returned for analysis.During the visual inspection of sample, the swage and attachment area were not as expected; since part of the swage area was raised (broken) ; however, during the handling of the needle this area breaking totally.This condition causes that the needle to be detached of the suture.Also, the suture was examined along of strand and no defects or damage were observed.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According the sample condition, the assignable cause of needle pull off is a needle breakage.
Event or Problem Description
It was reported that a cat underwent a spay procedure on (b)(6) 2018 and suture was used.The needle was not attached to the suture when the package was opened.During the visual inspection of the sample, the needle was found broken.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/04/2019.Additional information: evaluation: a failed suture needle was submitted for fractographic evaluation to assess the fracture mode of the failure.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was intergranular, which is evidence of a brittle failure.This was a non-ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the returned sample, the needle exhibited amounts of intergranular failure.

• Brand Name: MCRYL VIO 36IN 2-0 S/A SH
• 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: 8116574
• Report Number: 2210968-2018-77400
• Device Sequence Number: 16206237
• Product Code: GAN
• UDI-Device Identifier: 10705031059528
• UDI-Public: 10705031059528
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 04/30/2023
• Device Catalogue Number: Y732H
• Device Lot Number: MEM723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/04/2019
• Patient Sequence Number: 1