MAUDE Adverse Event Report: ETHICON INC. 2-0 MONOCRYL PLUS SUTURE PS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number MCP4271

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 01/01/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown surgery on an unknown date in 2024, and suture was used.The thread caught on the shuttle and weakened.No patient consequence was reported.Additional information was requested.

Manufacturer Narrative

(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.Additional information was requested, and the following was obtained: was there any adverse consequence associated with the patient? no harmful consequences.Could you kindly inform whether the product was utilized in the patient? if so, could you please indicate if there were any issues with the product (such as thread breakage, separation of thread from the needle, or any other incidents)? the thread broke and the surgeon just had to re-suture.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.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 when the surgeon had to re-suture (during the same procedure or reoperation was performed)? please specify.Attempts are being made to retrieve the device.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H6 component code: g07002 device not returned.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/1/2024.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Additional information was requested, the following was obtained: yes, i can confirm that the thread broke during the suture and that the surgeon had to re-suture and use a new thread.

• Brand Name: 2-0 MONOCRYL PLUS SUTURE PS-2
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18913040
• MDR Text Key: 337768412
• Report Number: 2210968-2024-02862
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP4271
• Device Lot Number: TLMBZX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• 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