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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2021 and suture was used.During use on the patient it was noted that the needle broke.There were no patient consequences reported.The missing part could not be found or discovered.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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.Photo analysis: upon visual inspection of image received for evaluation.An open paper lid and a broken needle at the tip product code vcp352h were observed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.Additional information was requested, and the following was obtained: what was the size of the needle used? 0-1 vicryl.Were x-rays performed to localize the needle? yes.Any additional tissue dissection damage due to searching for needle? no.Was more than half the needle retained in the patient? no.Where is the needle retained; in what structure? uterus and potential space.Was the procedure completed successfully? yes.Was there any adverse patient outcome? no.Procedure name and date? caesarean section with different dates.Event date? (b)(6) 2021.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.
Additional Manufacturer Narrative
Product complaint number: (b)(4).Date sent to the fda: 08/08/2022.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.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Two needles of product code: vcp352h were returned for analysis.A fracture was observed at the tips of sample a and sample b.Sample a was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.One side of sample b was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needles.The fracture surfaces were examined in multiple locations to determine the fracture mode.The fracture surface contained microvoid coalescence (mvc), a form of ductile failure.A cup-and-cone shaped fracture and macroscopic plastic deformation were noted.The fracture surface contained microvoid coalescence (mvc), a form of ductile failure.Mechanical damage in the form of indents and scratches were observed coincidental to the fracture.The evaluation of (b)(4) revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage and a cup-and-cone-shaped fracture provided additional evidence that the failures were induced by mechanical deformation leading to ductile overload.These were ductile fractures.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• 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: 14602522
• Report Number: 2210968-2022-04311
• Device Sequence Number: 17684325
• Product Code: GAM
• UDI-Device Identifier: 10705031052635
• UDI-Public: 10705031052635
• Combination Product (Y/N): Y
• Initial Reporter Country: JO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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