MAUDE Adverse Event Report: ETHICON INC. MONOCRYL PLUS SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP943G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an animal underwent an exploratory procedure after swallowing a golf ball on an unknown date in 2022 and suture was used.Opened a new box of 2/0 suture and it seemed to break a lot easier.No adverse consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information has been requested and received.If further details are received at a later date, a supplemental medwatch will be sent.Was there any adverse consequence associated with the patient? the patient/animal was here for having eaten a golf ball and was sick and having exploratory surgery.It was reported the monocryl 2/0 seemed to break a lot easier, when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.The suture broke during use in the patient.It broke when the dr.Was holding on to it putting tension on the suture when tying knots.It was reported that more than one packet of suture were open, what is the total number of products involved in this event? it was 2 packets.The other doctors in the practice do not seem to have had an issue with the suture since that patient that i have been made aware of.No product is available for return.Events reported on: mw# 2210968-2022-10798.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosantrade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional information was requested and the following was obtained: *the patient recovered and is doing well.*the suture broke during use in the patient.It broke when the dr.Was holding on to it putting tension on the suture when tying knots.*it was like the tissue was grabbing at the suture and did not pull through smoothly.*it was 2 packets of each size.The other dr's in the practice do not seem to have had an issue with the suture since that patient that i have been made aware of.

• Brand Name: MONOCRYL PLUS SUTURE 36"(90CM) 2-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125,; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16077648
• Report Number: 2210968-2022-10799
• Device Sequence Number: 6234779
• Product Code: GAM
• UDI-Device Identifier: 10705031218604
• UDI-Public: 10705031218604
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2023

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 Model Number: MCP943G
• Device Catalogue Number: MCP943G
• Device Lot Number: SHMDRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/04/2023; 02/02/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 12/30/2022; 01/19/2023; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown