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

Catalog Number MCP426H

Device Problems Break (1069); Defective Component (2292); 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  

Event Description

It was reported a patient underwent an unknown procedure on an unknown date in 2023 and suture was used.The suture broke easily during use.No reported patient consequences.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: handled more like a 5.0 suture.The surgeon commented that the suture felt thinner than usual.It was also reported that the suture was difficult to remove from the relay package.Three representative samples are being returned for analysis.Was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Can you identify the lot number of the product that was used? please provide the status of the device(s) as it has not been received for analysis.Note: events reported via: mw# 2210968-2023-08808 and mw# 2210968-2023-08809.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.

• 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: 18133751
• MDR Text Key: 328077699
• Report Number: 2210968-2023-08810
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031046504
• UDI-Public: 10705031046504
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K050845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP426H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2023
• 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