MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number MCP426H

Device Problems Break (1069); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4), date sent to the fda: 6/28/2023, h6 component code: g07002 - device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 information was requested, the following was obtained: was there any adverse consequence associated with the patient? no when were the six involved sutures broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify sutures broke both when removing from the suture tray and in the surgeons hands when suturing in the case please provide the lot number: lot number was reported in the initial pc report please provide the source or name of person providing answers to follow-up questions (b)(6).The following additional information was requested: it was reported that 6 sutures broke.How many of the 6 suture broke when removing from tray? how many of the 6 sutures broke when suturing? 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.Trade name - irgacare, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength - = 2360 g /m.Related reports: 2210968-2023-04686, 2210968-2023-04687, 2210968-2023-04688, 2210968-2023-04690, & 2210968-2023-04691.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the suture was difficult to remove from the suture tray resulting in several broken sutures and/or suture breaking in the surgeons hands due to stressed or damaged suture coming out of the tray.There were no patient consequences reported.Additional information was requested.

• Brand Name: MCRYL+ UD 27IN 4-0 S/A PS-2 PRM MP
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17218411
• MDR Text Key: 318052841
• Report Number: 2210968-2023-04689
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031046504
• UDI-Public: 10705031046504
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP426H
• Device Catalogue Number: MCP426H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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