MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-1 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1663G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, 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.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.This medwatch report is in response to receipt of facility report #mw5149676,.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, while suturing in doyle splints to the septum, the provider noted that the suture suddenly seemed dull and then quickly noted that the tip of the suture needle had broken off.No unusual force on the needle used that could explain the breaking of the needle.The end that had broken off was found immediately in the needle driver teeth and was removed from field.There were no adverse patient consequences.

• Brand Name: ETHLN BLK 18IN 3-0 S/A PS-1 PRM MP
• 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; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18658917
• Report Number: 2210968-2024-01047
• Device Sequence Number: 7128711
• Product Code: GAR
• UDI-Device Identifier: 10705031001725
• UDI-Public: 10705031001725
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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 Catalogue Number: 1663G
• Device Lot Number: TCBEKB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2023
• 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