MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 1 S/A CT CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP753D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 4/3/2024 h6 component code: g07002 - device not returned.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 review of the batch manufacturing records was conducted, and no related non-conformances were identified.Attempts have been 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.Additional information was requested, and the following was obtained via: * did a piece of the broken needle fall into the patient? if so, was it retrieved? ¿ yes, the needle broke off into patient & was visibly retrieved.* what was done to retrieve/search for the broken piece? ¿ magent was used to locate & retrieve the broken piece.* 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), clinical lead.Rep called to provide that a second device for the same product was used that had a similar issue to the first device reporting.Facility was unsure which lot number it was associated with so she provided three of them with the expiration date.She will send back the device within the same box as the first one: tdmetq 3/31/2028 tlmasb 9/30/2028 tlmetq 3/31/2028.The following information was requested: a device was received for product code y303h lot#tdmetq.However, lots tlmasb and tlmetq were previously reported.Please confirm if product code y303h lot tdmetq, y303h lot tlmasb and product code vcp753d lot tlmetq belongs to this complaint.Did needle breakage occur during the same procedure for all three lots?.
Event or Problem Description
It was reported that a patient underwent a vaginal plasty procedure on (b)(6) 2024 and suture was used.During the procedure, the sales rep that the needle broke in half during a vaginal plasty procedure.They were able to get another device to complete the case without patient harm.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ VIO 8X18IN 1 S/A CT CR
• 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: 19034017
• Report Number: 2210968-2024-03808
• Device Sequence Number: 15461116
• Product Code: GAM
• UDI-Device Identifier: 10705031055339
• UDI-Public: 10705031055339
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: VCP753D
• Device Lot Number: TLMETQ
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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