MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J442H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent plastic surgery on (b)(6), 2024, and suture was used.During the procedure, nineteen out of thirty-six sutures broke at the needle connection; needle and suture simply separated, no fragments were generated.The surgeon tried more sutures from same box then eventually opened a new box, the remaining seventeen were not used.Procedure was completed successfully with an unknown delay.There was no patient consequence.Additional information has been 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.The following information was requested, but unavailable: were there any unexpected outcomes or complications as a result of the prolonged surgery time? how long (in minutes) did the surgery prolong? what tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post operative care due to the prolonged procedure? attempts are being 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.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Related events captured via 2210968-2024-04552, 2210968-2024-04553, 2210968-2024-04554, 2210968-2024-04555, 2210968-2024-04556, 2210968-2024-04557, 2210968-2024-04558, 2210968-2024-04559, 2210968-2024-04560, 2210968-2024-04562, 2210968-2024-04563, 2210968-2024-04564, 2210968-2024-04565, 2210968-2024-04566, 2210968-2024-04567.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 5/2/2024.Additional information was requested, the following was obtained: all available info was included with the original submission.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.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19139612
• Report Number: 2210968-2024-04559
• Device Sequence Number: 9402465
• Product Code: GAM
• UDI-Device Identifier: 10705031039933
• UDI-Public: 10705031039933
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: J442H
• Device Lot Number: TMMDAT
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• 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