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

Model Number	664H
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent excision of multiple skin lesions on (b)(6) 2023 and suture was used.The whole lot was very fragile, the wrapper would easily tear and deteriorate when opening.The plastic holder/case would easily crack with little force and the suture string itself was breaking while the surgeon was using it.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional 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: was there any adverse consequence associated with the patient? there was no adverse consequence associated with the patient.What is the total number of products involved in this event? according to the nurse, only 1 suture broke during use.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: ETHLN BLK 18IN 2-0 S/A FS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16599845
• Report Number: 2210968-2023-01992
• Device Sequence Number: 6094061
• Product Code: GAR
• UDI-Device Identifier: 10705031007826
• UDI-Public: 10705031007826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 664H
• Device Catalogue Number: 664H
• Device Lot Number: PCQ260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown