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

Catalog Number	VCP346H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/23/2024.H6 component code: g07002 - device not returned.H6 component code: c22 - photo analysis.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 manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: were there patient consequences? if yes, please specify.Answer: none, the needle was found.What measures were taken to retrieve the needle? answer: xray/ct scan was used to locate the needle.Was there any additional tissue damage as a result of searching for the needle? answer: none.How long was the delay? please specify in minutes.Answer: 30 minutes to 1 hour.Was there any change in the patient¿s post-operative care due to the prolonged procedure? answer: none.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).Answer: (b)(6), orthopedic or nurse.The following information was reported: was surgery delayed due to the reported event? --> yes, if yes, number of minutes: --> not recorded, action taken when event occurred? --> ct scan to locate the needle, was procedure successfully completed? --> yes, were fragments generated? --> yes, if yes, were they removed easily without additional intervention? --> yes, patient status/ outcome / consequences --> , patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown.Photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a winding former labeled vcp346 with an apparent needle detachment, the suture of observed tangled around the winding.A clear analysis of the failure end point or needle hole could not be performed due to the position of the needle.Based on the photo review, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure (amputation stump closure) on (b)(6) 2024 and suture was used.It was reported that the thread was detached from the needle during closure intra-op while closing the stump.The case is leg amputation.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20515137
• Report Number: 2210968-2024-10997
• Device Sequence Number: 20610662
• Product Code: GAM
• UDI-Device Identifier: 10705031052574
• UDI-Public: (01)10705031052574(17)290228(10)UA2AQQ
• Combination Product (Y/N): Y
• Initial Reporter Country: RP
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: VCP346H
• Device Lot Number: UA2AQQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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