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

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2024

Event Type  Injury  

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.Component code: g07002 device not returned 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 date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? what instruments were used to grasp the needle? where was the needle grasped during use? please clarify the issue with the ethicon product: did the suture break? or did the needle pull off suture? or did the needle break? what was the size of the needle used? what specific part of the ethicon product remained embedded in the patient? what is the size of the ethicon product that became embedded in the patient? were x-rays taken to locate the ethicon product? was the ethicon product retrieved during the same procedure? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the broken piece? please describe any medical/surgical intervention required for this suture event including dates and results.Does a piece of the broken ethicon product remain in the patient¿s tissue? in what structure/tissue is the broken ethicon product located? is there any plan in place to remove the broken ethicon product in the future? if yes, please provide the scheduled date.What is the surgeon's opinion of consequences to the patient? 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 is the patient's current status? product code and lot number? surgeon¿s name?.

Event Description

It was reported that a patient underwent an unknown procedure and suture was used.During the procedure in the er, the suture broke off and was imbedded in the patient.Additional information was requested.

• 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: 18610445
• MDR Text Key: 334140339
• Report Number: 2210968-2024-00796
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• 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
• Patient Outcome(s): Other