MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y922H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
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.Additional information was requested and the following was obtained: please clarify what is meant by the, ¿ligature was found slipped.¿ the surgeon who performed the second surgery said it was very odd and that the tissue around the ligature seemed "different" the ligature itself had slipped off.Did the suture break post-operatively? yes, the dog had recovered and then seemed to worsen after about 2 hours.Did the suture knots untie post-operatively? i don't think so.It almost seemed to have been described to me as if the know was still tight, but that the tissue itself was no longer present as you would expect.Did the suture absorb pre-maturely? no.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 an ovariohysterectomy animal procedure on (b)(6) 2018 and a suture was used.The suture broke post-operatively.

• Brand Name: MCRYL VIO 36IN 4-0 S/A FS-2
• 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: 8209918
• Report Number: 2210968-2019-78114
• Device Sequence Number: 16571555
• Product Code: GAN
• UDI-Device Identifier: 10705031059856
• UDI-Public: 10705031059856
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 12/03/2018

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: 07/31/2022
• Device Catalogue Number: Y922H
• Device Lot Number: LJM746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1