MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP352H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: what was the size of the needle used? 40mm.Was more than half the needle retained in the patient? only the tip.Where is the needle retained; in what structure? n/a (hcp needed more clarification) is the needle still in the patient? if so which structure (tissue, bone, cavity, etc) is the needle retained in? was there any additional tissue damage as a result of searching for the needle piece? no.Are there plans to remove the retained needle piece? no.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no.Was there any change in the patient care as a result of this event? further xray and hospital stay.Patient¿s current status? healthy and discharged.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 this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength -= 275 g /m.
Event or Problem Description
It was reported that a patient underwent a cesarean section procedure on (b)(6) 2021 and suture was used.While suturing the needle tip broke and it is suspected it still inside the patient abdomen.The procedure was delayed 30 minutes in order to do more exploration to try to find the tip.The tip was not found, and the patient was closed.The patient went for an x-ray.There are no plans to remove the suspected retained needle.There were no unexpected outcomes or complications as a result of the prolonged surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/12/2022.H6 component code: g07002 - device not returned.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, and the following was obtained: 1.Is the needle still in the patient? only the tip.2.If so which structure (tissue, bone, cavity, etc) is the needle retained in? tissue (uterus).
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/8/2022.H3 investigational summary: a failed suture needle was submitted to fractographic evaluation.The component was identified as product code vcp352h.It was requested that assess the fracture mode of the failure.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Based on the information currently available, the needle breakage was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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+ VIO 27IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert- koch strass1; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12976934
• Report Number: 2210968-2021-12485
• Device Sequence Number: 17364229
• Product Code: GAM
• UDI-Device Identifier: 10705031052635
• UDI-Public: 10705031052635
• Combination Product (Y/N): Y
• Initial Reporter Country: SA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2022

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 Expiration Date: 01/31/2024
• Device Model Number: VCP352H
• Device Catalogue Number: VCP352H
• Device Lot Number: RBBCKKW0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 01/13/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/12/2022; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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