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

Catalog Number	664H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a bilateral brachioplasty, bilateral mastopexy, bilateral breast augmentation with silicone implant on (b)(6) 2024 and suture was used.During the procedure; while using a nylon suture, surgeon noted damage to suture needle.Broken part observed by surgeon and rnfa to fall on patient skin.Both pieces examined by surgical team and passed off the field for later review.X-ray was requested to rule out potential retained portion.X-ray was negative, no retained suture, closure resumed.Suture needle and packaging saved for later review.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/19/2024.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 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: can you identify the product code of the product that was used? i am not sure what the product code is.I can include a photo of the suture packaging.There are a few other numbers on the packaging, but i am not sure what they are.This would be xj664.P32.Another one is ce2797.Not sure if this helps.Is this device or samples available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number).This product is available.Please send the shipper kit to (b)(6).Materials management.(b)(6).His email address is (b)(6).A contact number for him should be (b)(6).I will also include (b)(6) on this email, so he is aware.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).(b)(6) is a supervisor for resource management.My name is (b)(6), and i am a clinical risk analyst with risk management.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.Medwatch was previously reported #mw (b)(4).
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: is this device or samples available for analysis? -- unfortunately, this device is no longer available to be sent back for investigation.We were unaware originally that the device had been discarded.

• 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; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19143088
• Report Number: 2210968-2024-04586
• Device Sequence Number: 15322853
• Product Code: GAR
• UDI-Device Identifier: 10705031007826
• UDI-Public: 10705031007826
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: 664H
• Device Lot Number: TPBBHU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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