MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A V-7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8845
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2023 and suture was used.During the procedure, the sutures break too easily when tying the vessel.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 9/14/2023.H6 component code: g07002 - pending evaluation of returned device.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 device has been received for product code w8845, lot scbhha, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, the following was obtained: what is the total number of products involved in this event? he said total 37 ea are involved.Did all 37 sutures break during use during this one patient surgery? or are 37 sutures being returned for analysis? the products will be returned for analysis.4-5 of 37 returned unit were broken.The hospital returned all hospital inventory of same lot number.Related reports: 2210968-2023-03467, 2210968-2023-03468, 2210968-2023-05359, 2210968-2023-05360, 2210968-2023-05361.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/15/2023.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device the returned samples determined that it was received twenty-five unopened samples that pertain to the product code w8845.As per the sampling plan, a visual inspection was performed on thirteen samples, and no defects were found on the packages.The packets were opened, and the swage and attachment area were noted 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 instron 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: 2210968-2023-03467, 2210968-2023-03468, 2210968-2023-05359, 2210968-2023-05360, 2210968-2023-05361, & 2210968-2023-06674.

• Brand Name: PRLNE BLU 36IN 4-0 D/A V-7
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17744388
• Report Number: 2210968-2023-06674
• Device Sequence Number: 12175977
• Product Code: GAW
• UDI-Device Identifier: 10705031231726
• UDI-Public: 10705031231726
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133356
• 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): 09/15/2023

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 Catalogue Number: W8845
• Device Lot Number: SCBHHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown