MAUDE Adverse Event Report: ETHICON INC. CATGUT PLAIN 3-0 70CM (1)SH-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number G318T

Device Problem Material Separation (1562)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a tonsillectomy procedure on 28-feb-2024 and suture was used.During suture of the left tonsil site, the needle detached entirely from the thread inside the mucosa and muscle plane.It was quickly located in the lower pole soon after it occurred.Additional information was requested.

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.H6 component code: g07002 device not returned attempts have been 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.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize the needle? does the needle remain retained in the patient's tissue? if retained, where is the needle located/in what structure? if retained, were there any patient consequences? if retained, are there plans for removal of the needle? please describe any medical/surgical intervention required for this suture event including dates and results.What is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Related medwatch reports: 2210968-2024-03474, 2210968-2024-03475.

• Brand Name: CATGUT PLAIN 3-0 70CM (1)SH-1
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18981665
• MDR Text Key: 338726868
• Report Number: 2210968-2024-03474
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G318T
• Device Lot Number: AU4444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2023
• 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