MAUDE Adverse Event Report: ETHICON INC. VCL UC MONO VIO 12IN 10-0 D/A CS160-8; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	V450G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date in 2023 and suture was used.The needle on the end of suture popped off during tying and needle lost.Replaced with a new lot.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.Was surgery delayed due to the reported event? unknown.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study unknown.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.If this event occurred in multiple procedures, please provide information requested above for each patient event.1.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).2.What are the procedure name(s) and date(s)? 3.What is the quantity involved per procedure 4.Can you identify the lot number of the product that was used? 5.Was there any adverse patient consequence(s) or subsequent medical/surgical intervention? no product is available for return.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Note: related events reported on: mw# 2210968-2023-06486, mw# 2210968-2023-06487.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, 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.

• Brand Name: VCL UC MONO VIO 12IN 10-0 D/A CS160-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125,; col salvacar; ciudad juarez, 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17710273
• Report Number: 2210968-2023-06486
• Device Sequence Number: 2250934
• Product Code: GAM
• UDI-Device Identifier: 10705031051270
• UDI-Public: 10705031051270
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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: V450G
• Device Lot Number: TDMHJJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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