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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Pocket Erosion (2013); Impaired Healing (2378)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a procedure for a rupture of the left ring extensor tendon on (b)(6) 2023 and suture was for the anastomosis.Poor wound healing.Post-op, on the 8th day after the surgery, the patient's incision showed exposure of the purulent tendon anastomosis suture, resulting in poor wound healing.After removing the suture, the incision healing improved.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.H6 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.The following information was requested but unavailable: please provide the patient's demographic information including age, gender, weight, bmi at the time of index 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)? how was the suture tied (square knot or multiple knots one end)? did the wound dehis? if yes, what tissue dehisced? did the suture extrude? did the suture break post-op? please describe any medical/surgical intervention required for this suture event including dates and results.After suture removal, was re-suturing required? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? did the patient have an infection? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.Were any pre-op cleansing procedures changed recently? if yes, please describe were there any patient stress factors that precipitated the event? 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?--contacted with the sales rep today via phone, please refer to the event description, other information requested is unknown.

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: after investigation, the patient was a 33-year-old male.On (b)(6) 2023, the patient underwent tendon rupture anastomosis in hospital due to "left ring extensor tendon rupture".The surgeon used suture (with specific product code unknown) to perform the tendon sewing in the way of interrupted suturing during the operation.The operation went smoothly.8 days after the surgery, the patient had incision pus discharge, the suture on incision was discharged from wound, and the incision showed poor healing condition.The doctor removed the suture for treatment, after which the patient's incision healing was improved.No subsequent adverse event reports were received.

• 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: 18169244
• MDR Text Key: 328599059
• Report Number: 2210968-2023-09039
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Male