MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 6-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	667G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: what tissue was being approximated or sutured when it broke? tissue approximated.What was used to complete the procedure? skin closure.Was the procedure successfully completed? yes.Please provide the lot number for the involved device.Qgbbqh.Please provide the procedure name and date.Not provided from the customer.In the event description is sounds like 1 device had an issue.However, according to the impacted product page it says 6 products were involved.The physician said comparing to other batches this batch is easier to be broken.How many products were involved? if more than 1, what was the issue with the other devices? 667g 4~5 ea broken while using normally.Events reported via: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown surgery in 2021, and suture was used.During the skin closure, the suture broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 6/03/2021.H6 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, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: ETHILON SUTURE 18"(45CM) 6-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11616617
• Report Number: 2210968-2021-03039
• Device Sequence Number: 19757286
• Product Code: GAR
• UDI-Device Identifier: 10705031007871
• UDI-Public: 10705031007871
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 05/31/2025
• Device Model Number: 667G
• Device Catalogue Number: 667G
• Device Lot Number: QGBBQH
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1