MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP497G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.A manufacturing record evaluation was performed for the finished device lot number ramles and no non-conformances related to the reported complaint condition were identified (b)(4).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.Additional information was requested and the following was obtained: what was the initial procedure? related to obstetric case did the surgery was completed successfully? if yes, yes, the surgery was successfully with new product.What was used to complete the procedure? the doctor used the new one.Could you please confirm if the patient suffer from any consequence due to the issue (breakage suture)? no, there is no patient impacted.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.
Event or Problem Description
It was reported that a patient underwent an obstetric procedure on (b)(6) 2021 and a barbed suture was used.During the procedure, the suture was broken when used.Another like device was used to successfully complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: MCRYL+ UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12608280
• Report Number: 2210968-2021-09482
• Device Sequence Number: 4023809
• Product Code: GAM
• UDI-Device Identifier: 10705031046603
• UDI-Public: 10705031046603
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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: 12/31/2022
• Device Model Number: MCP497G
• Device Catalogue Number: MCP497G
• Device Lot Number: RAMLES
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/11/2021
• Patient Sequence Number: 1