MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 5-0 S/A FS-2; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number 661H

Device Problem Material Frayed (1262)

Patient Problem Skin Discoloration (2074)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Component code: (b)(4).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.Additional information was requested and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Name of the index surgical procedure? woman, (b)(6) years old.I do not have the present weight and length, but the person has a normal bmi.Operation time: 15 minutes.Removal of foreign body dig iv sin.The diagnosis and indication for the index surgical procedure? diagnostic code : (b)(6).Remaining foreign body.On what tissue was the suture used? epidermis, dorsal of dig iv sin.Did the suture fray during use? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? none.How much skin had to be removed due to the small particles coming off from the suture? please provide specifics if possible.2x2 mm of skin n dorsal to dip-joint in finger.Was any additional medical/surgical intervention required for the area where the skin was removed?: a straight incision and suture line had to be extended to a t-shaped.What is the patient's current status? just fine.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that a patient underwent a procedure to remove a foreign body in digit iv on (b)(6) 2021 and suture was used.While closing the wound they discovered that there were coming of small particles from the suture and the skin was colored black were the suture had passed through the skin.To make sure not to leave any particles left in the skin they had to remove a bit of skin.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).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.Additional information was requested and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Name of the index surgical procedure? woman, (b)(6) years old.I do not have the present weight and length, but the person has a normal bmi.Operation time: 15 minutes.Removal of foreign body dig iv sin.The diagnosis and indication for the index surgical procedure? diagnostic code : m.79.5.Remaining foreign body.On what tissue was the suture used? epidermis, dorsal of dig iv sin.Did the suture fray during use? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? none.How much skin had to be removed due to the small particles coming off from the suture? please provide specifics if possible.2x2 mm of skin n dorsal to dip-joint in finger.Was any additional medical/surgical intervention required for the area where the skin was removed?: a straight incision and suture line had to be extended to a t-shaped.What is the patient's current status? just fine.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that a patient underwent a procedure to remove a foreign body in digit iv on (b)(6) 2021 and suture was used.While closing the wound they discovered that there were coming of small particles from the suture and the skin was colored black were the suture had passed through the skin.To make sure not to leave any particles left in the skin they had to remove a bit of skin.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/10/2022.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: d9, h6 additional h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: an empty opened box, twenty-seven packets, a paper lid, and an empty winding of product code 661h were returned for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to fraying or damaged suture and no defects were observed during evaluation.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: ETHLN BLK 18IN 5-0 S/A FS-2
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12967819
• MDR Text Key: 286127015
• Report Number: 2210968-2021-12446
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031007703
• UDI-Public: 10705031007703
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 661H
• Device Catalogue Number: 661H
• Device Lot Number: RHBEPH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female