MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y967H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 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.
Event or Problem Description
It was reported that an animal underwent a spay procedure on (b)(6) 2018 and a suture was used.During surgery, the doctor noticed that every time he tried to tie the suture the suture would break with little to no pressure.When he would go to tighten the knot on the suture it would break, the suture was very brittle.A replacement device was used to complete the procedure.There were no adverse consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/15/2019.Evaluation: an empty opened foil and a needle/suture product was returned for analysis.During the visual inspection of the sample, showed multiples wrinkles and pin holes on bottom foil (from outside to inside).The swage and attachment area were noted to be as expected.The suture was examined along of strand and no defects were noted; however, during the functional test the suture was broken; since has begun with the process of degradation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of performance breakage suture, was caused by suture degradation exposure to environment.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 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: 8161822
• Report Number: 2210968-2018-77739
• Device Sequence Number: 11355548
• Product Code: GAN
• UDI-Device Identifier: 10705031059993
• UDI-Public: 10705031059993
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/20/2018

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: 12/31/2021
• Device Catalogue Number: Y967H
• Device Lot Number: LAM146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1