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

Model Number	VCP340H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2021 and suture was used.It was reported that the suture broke and the wound was opened.It is unknown when the event occurred.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that "the suture broke and wound opened.They happened with another patient last week.They pulled all the vycryl o with the ct1 needle with the lot numbers".Two files were opened to capture each patient: patient 1: (b)(4).Patient 2: (b)(4).For each of the two patients, please provide the following: please provide the product code and lot number.When did the event occur? intra-op or post-op? procedure date? if post-op, what post-op date after surgery did the dehiscence occur? was there any medical or surgical intervention performed to treat the opened wound (re-operation; re-suturing; prescription steroids; antibiotics prescribed)? if so, please clarify.What is the most current patient status? trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.Note: events reported: 2210968-2021-12696 and 2210968-2021-12698.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary : sixty-six packets of product code vcp340h 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.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area was 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 suture 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional investigation summary : an opened box with eleven packets of product code vcp340 were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the packets 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 of the strand to detect any issue related to damaged or breakage suture and no defects were observed during evaluation.Functional test was performed, and the tensile strength result were 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Device history lot : a manufacturing record evaluation was performed for the finished device batch rkmhqu, vcp340h and no non-conformances were identified.Mfg.Date - sep/15/2021.Exp.Date - aug/31/2026.Device history lot : a manufacturing record evaluation was performed for the finished device lot number qa2aeq / vcp340h32 and no non-conformances related to the reported complaint condition were identified.Mfg.Date: jan/13/2020.Exp.Date: dec/31/2024.Additional information was requested and the following was obtained: when did the event occur? intra-op or post-op? : post-op.Procedure date? : procedure date previously communicated, unknown at this time.If post-op, what post-op date after surgery did the dehiscence occur? was there any medical or surgical intervention performed to treat the opened wound (re-operation; re-suturing; prescription steroids; antibiotics prescribed)? if so, please clarify.: patient was readmitted.What is the most current patient status? : current patient status unknown.Please provide the status of the device(s).: representative samples returned.Used devices were not available for return.

• Brand Name: VCL+ VIO 27IN 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13025489
• Report Number: 2210968-2021-12697
• Device Sequence Number: 20093829
• Product Code: GAM
• UDI-Device Identifier: 10705031052499
• UDI-Public: 10705031052499
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: VCP340H
• Device Catalogue Number: VCP340H
• Device Lot Number: QA2AEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 01/26/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/14/2022; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown