MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP316H
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
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 12/20/2023.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 no device problem found.Additional information was requested, the following was obtained: did breakage suture occur for both lot tamatx and tambsd during the same procedure? yes.Additional information was requested, the following was obtained: how long was the delay in the procedure? no delay.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? no.Was there any additional treatment required and/or adverse patient outcome due to the prolonged surgery? no.No consequence to patient.Surgery was completed successfully.The following information was requested but unavailable: when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify were there any patient consequences? procedure/event date? (previously reported in follow up 1 - mw # 2210968-2023-06769) h3 investigational summary: h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received, sixteen unopened samples that pertain to the product code pdp316h.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, the 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.Related reports: 2210968-2023-06769.
Event or Problem Description
It was reported that a patient underwent an esophagus procedure on an unknown date and suture was used.During the procedure, the suture was breaking.The surgery was delayed due to the reported event.It was unknown how the procedure was completed.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PDS+ VIO 27IN 3-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18368402
• Report Number: 2210968-2023-09986
• Device Sequence Number: 20775135
• Product Code: NEW
• UDI-Device Identifier: 10705031048027
• UDI-Public: 10705031048027
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K061037
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: PDP316H
• Device Lot Number: TAMBSD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 11/23/2023; 01/18/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown