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

Model Number	VCP340H
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: 3 sutures total on 3 patients (1 per patient).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.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what tissue dehisced? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? were all 3 sutures (lots rkmhqu, rh2ame, qa2aeq) used on this patient and broke post-op? what medical/surgical intervention was performed when the patient was readmitted to the hospital? please include dates and results.Please describe the appearance of the suture during a second procedure, if applicable.Were there any precipitating stress factors for the suture breakage post-op? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? investigative 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 additional investigative 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.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.A manufacturing record evaluation was performed for the finished device batch rkmhqu, vcp340h and no non-conformances were identified.Trade name - (b)(4).Related medwatch reports: 2210968-2021-12698, 2210968-2021-12701.
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.Additional information was requested.

• 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.-SAN ANGELO; 3348 pulliam st; san angelo TX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13476836
• Report Number: 2210968-2022-00894
• Device Sequence Number: 5437462
• Product Code: GAM
• UDI-Device Identifier: 10705031052499
• UDI-Public: 10705031052499
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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