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

Catalog Number Y464G

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

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 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.

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
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7524694
• MDR Text Key: 108656678
• Report Number: 2210968-2018-72884
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059269
• UDI-Public: 10705031059269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: Y464G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 06/04/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1