MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y464G
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The following possible batch numbers: batch ld6909, mfg date: 04/27/2017, exp date: 03/31/2022.Batch lkz626, mfg date: 09/18/2017, exp date: 08/31/2022.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.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 or Problem Description
It was reported that an animal underwent a dental procedure on (b)(6) 2018 and suture was used.During the procedure, the suture popped off the needle during a simple interrupted suture line.Another like device was used to complete the procedure.There were no adverse consequences for the animal.No additional information was provided.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.An empty opened foil, a used needle and suture piece were returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.The barrel hole of the needle it was observed damaged (crushed).Marks on the edge appears to be by the use of a surgical instrument.The suture piece was examined along of the strand and damaged (dent) were observed on the end, also the end was cut appears to be by the use of a surgical instrument.According to the sample condition, the assignable cause of performance-pull off suture needle, suggest an improper handling of sample.

• Brand Name: MCRYL VIO 18IN 4-0 S/A P-3 PRM MP
• 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: 7524694
• Report Number: 2210968-2018-72884
• Device Sequence Number: 1696505
• Product Code: GAN
• UDI-Device Identifier: 10705031059269
• UDI-Public: 10705031059269
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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 Catalogue Number: Y464G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1