MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

Catalog Number SUTUREUNK

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture had broke three times on a single patient creating an event report.Unknown how the procedure was completed.Unknown if three sutures are available for returned.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Component code: g07002 - device not returned.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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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: could you please clarify if the patient suffered from any signs or consequence due to the issue? please provide more information what is the product code & lot number? device return follow up.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.Related reports: 2210968-2023-01428 and 2210968-2023-01429.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 3/24/2023.Additional information was requested, the following was obtained: it was reported by the account contact that during an unknown procedure, had a suture break three times on a single patient creating an event report.Unknown how the procedure was completed.Unknown if three sutures are available for return.Procedure was thigh lift could you please clarify if the patient suffered from any signs or consequences due to the issue? please provide more information.The patient did not suffer from the needle breaking on the 3-0 monocryl what is the product code & lot number? the product code and lot were not retained., we did keep the suture and it is available for return.Device return follow-up.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.Related reports: 2210968-2023-01428, 2210968-2023-01429, and 2210968-2023-01430.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 4/3/2023.The following additional information was requested: according to the additional information received, "the patient did not suffer from the needle breaking on the 3-0 monocryl".Please clarify the issue that occurred during the procedure.It was reported that 3 sutures broke.How many of the 3 devices had suture breakage during the procedure? how many of the 3 devices had needle breakage during the procedure? 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.Related reports: 2210968-2023-01428 & 2210968-2023-01429.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• 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: 16471211
• MDR Text Key: 310689739
• Report Number: 2210968-2023-01430
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SUTUREUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2023
• 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