MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 2-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP443H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an abdominoplasty and breast augmentation procedure in (b)(6) 2022 and suture was used.During the procedure, the suture broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).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, and the following was obtained: were there any alleged breakage suture with these 12 devices (sutures)? please clarify.Finally 2 sealed boxes(36+36) and 2 opened boxes with 12 and 23 packets left will be shipped for evaluation and haven¿t been used.27 sutures were used in total.Some of them on patient but those weren¿t problematic without any impact on patient, some of them were not used on patient because breakage was observed before use.Please confirm the specific number of patient events, per suture product and the quantity of sutures involved? exact number is unknown.How many impacted devices were used on patients? please create a file for each incident/each patient: exact number is unknown.Please specify patient consequences if any for each patient? no consequences.Have any of these events been previously reported to ethicon? if yes, please provide the pc number.No previous product complaints with this product code recently.If there are additional patient events and pcs have not been created, please create the additional pcs.No other event.Procedure name and date? abdominoplasty, breast augmentation product will be shipped on (b)(6) 2022.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 - (b)(6).Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength - 275 g /m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/15/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.H6 component code: g07002 no device problem found.H3 investigational summary: visual analysis of the returned product revealed that a needle-suture piece and a suture piece product code vcp443h were received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the swage and attachment area of the needle were noted to be as expected, a suture piece still attached to barrel hole and the suture pieces were observed with body fluids and the ends cut possibly from a surgical instrument.The product code vcp344 contains absorbable suture, as the sample was received open, the time of exposed to the environment could not be determined and functional test cannot be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional h3 investigational summary: two sealed boxes (36ea.) and two opened boxes with twelve and twenty-three packets ea.Of product code vcp443h were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection of the samples, no external damages were observed on the packets.As per the sampling plan, visual inspection was performed to twenty-two samples packets that were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.Functional test was performed, and the tensile strength result was above the minimum requirements.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Trade name - irgacare, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength -= 275 g /m.

• Brand Name: VCL+ UD 27IN 2-0 S/A FS-1
• 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: 13543791
• Report Number: 2210968-2022-01119
• Device Sequence Number: 19763077
• Product Code: GAM
• UDI-Device Identifier: 10705031053311
• UDI-Public: 10705031053311
• Combination Product (Y/N): Y
• Initial Reporter Country: EZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: 10/31/2024
• Device Model Number: VCP443H
• Device Catalogue Number: VCP443H
• Device Lot Number: RMBDLQS0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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