MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 12IN 7-0 D/A TG140-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J566G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Component code: (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.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 via: in event description mention about 4 different procedures where the suture got broken: were these cases previously reported to ethicon? the doctor did all of these procedures in this one case, per sales rep.If yes, please provide a complaint reference number.If no, please create additional complaint files and provide the reference number.Could you please clarify how many devices present this issue (breakage suture) during this single procedure? two broke, per sales rep.Please clarify if the surgery prolonged occurred in this procedure or in the others procedures? unknown.Could you please clarify if the wound dehiscence occurred post op? unknown.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.No.Was there any change in the patient¿s post-operative care due to the prolonged procedure? unknown.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? unknown.How long (in minutes) did the surgery prolong? unknown.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.Events reported via: 2210968-2022-10099.
Event or Problem Description
It was reported that a patient underwent a penile adhesion lysis, circumcision, penile chordee correction and scrotoplasty procedure in 2022 and suture was used.During the procedure, it was reported that the doctor has complained of wound dehiscences happening with the 7-0 suture.He has had some suture breaking while knot tying.During a penile adhesion lysis, circumcision, penile chordee correction, and scrotoplasty.Two separate sutures broke during knot tying.The suture is from the same box and lot number.Unknown how many minutes the surgery was delayed.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/28/2022.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that it was received twelve unopened samples that pertain to the product code j566g.In order to evaluate the condition of the returned samples, no defects were found on the packages.The packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.Also, a functional test was performed using instro equipment and 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.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.Related reports: 2210968-2022-10100, 2210968-2022-10099.

• Brand Name: VCL CT BRD VIO 12IN 7-0 D/A TG140-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15936211
• Report Number: 2210968-2022-10100
• Device Sequence Number: 6346484
• Product Code: GAM
• UDI-Device Identifier: 10705031041264
• UDI-Public: 10705031041264
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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 Model Number: J566G
• Device Catalogue Number: J566G
• Device Lot Number: SHMPLX
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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