MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 2-0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J517H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Post-op, the suture had loosened/gone up a few days after suturing.The patient needed to be re-sutured because the suture ruptured 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 device not returned.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.Additional information was requested, and the following was obtained: were there any patient consequences? patient needed to be re-sutured if medication was required, please clarify if it was prescription strength.No was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Patient needed to be re-sutured because the suture rupture 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 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.)? did the wound dehis? if yes, what tissue dehisced? did the knots untie post-op? did the suture break post-op? please describe the appearance of the suture during the second procedure/time of re-suturing.Please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? were there any precipitating patient stress factors for the event? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? will the product be returned? if so, please provide the return date and tracking information.
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.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: no further information date and name of index surgical procedure? : no further information the diagnosis and indication for the index surgical procedure? sutured for a grade 1 or grade 2 rupture after delivery what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open on what tissue was the suture used? vaginal tissue what was the tissue condition (normal, thin, calcified, fragile, diseased)? no further information how was the suture placed (interrupted or continuous)? no further information how was the suture originally tied (multiple knots, square knot, etc.)? no further information for any patient did the wound dehis? patient had to be resutured if yes, what tissue dehisced? no further information did the knots untie post-op? no further information did the suture break post-op? yes please describe the appearance of the suture during the second procedure/time of re-suturing.No further information please describe any medical/surgical intervention required for this suture event including dates and results.No further information did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no further information were there any precipitating patient stress factors for the event? no further information what symptoms did the patient experience following the index surgical procedure? onset date? no further information other relevant patient history/concomitant medications? no further information what is the physician¿s opinion as to the etiology of or contributing factors to this event? no further information what is the patient's current status? no further information.
Additional Manufacturer Narrative
Product complaint#: (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.Investigation summary: the product was returned to ethicon for evaluation.The returned samples determined that it was received twenty-eight unopened samples that pertain to the product code: j517h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of the 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.

• Brand Name: VCL CT BRD VIO 36IN 2-0 S/A V-34
• 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 strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18539876
• Report Number: 2210968-2024-00505
• Device Sequence Number: 20732124
• Product Code: GAM
• UDI-Device Identifier: 10705031040854
• UDI-Public: 10705031040854
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K022269
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2024

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 Catalogue Number: J517H
• Device Lot Number: TDBDHDA0
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 01/31/2024; 04/02/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/08/2024; 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown