MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 0 S/A CTB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCPB946H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
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.H3 analysis summary: the product was returned to ethicon for evaluation.The returned product determined that it was received, one labeled winding former with a partially dispensed suture and a detached needle that pertained to product code vcpb946h.Upon visual inspection of the returned sample, no breakage suture was observed.The sample was tested to verify the dispensability of the suture and it was not possible due to the suture being found hard to release from the tray by applying excessive force.This condition caused the needle to be detached from the suture.This product code contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.Based on the information currently available, the indispensable suture was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a breast reconstruction surgery on (b)(6) 2024 and suture was used.The suture was broken when the surgeon attempted to sew subcutaneous tissue.Changed to another two to continue the surgery and the suture was broken when the surgeon attempted to sew skin.Changed to another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.

• Brand Name: VCL+ UD 36IN 0 S/A CTB-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: 19454335
• Report Number: 2210968-2024-05744
• Device Sequence Number: 8558764
• Product Code: GAM
• UDI-Device Identifier: 10705031056725
• UDI-Public: 10705031056725
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• 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

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: VCPB946H
• Device Lot Number: SLMLRQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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