MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y416H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The product upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported by vet that the animal underwent an animal procedure in 2018 and the suture was used.After the procedure, the internal sutures dissolved within a few days of the procedure.No additional information has been requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Investigation summary unopened samples were returned for analysis and were examined for visual defects: appearance, color packages, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured).The packets were opened and during the visual inspection, the sutures were correctly placed on the winding former and the sutures were dispensed without problems and examined along of the strands and no defects or damaged were observed, the sutures not presented defects.A functional test was performed and tensile force were above the minimum requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no defects were observed on the packet or the suture and the tested samples met the finished goods requirements.

• Brand Name: MCRYL UD 27IN 3-0 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: 7643232
• Report Number: 2210968-2018-73891
• Device Sequence Number: 16752888
• Product Code: GAN
• UDI-Device Identifier: 10705031059122
• UDI-Public: 10705031059122
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• 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): 06/05/2018

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: No Information
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: Y416H
• Device Lot Number: LKZ161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/07/2018
• Patient Sequence Number: 1