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	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/4/2024.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.Additional information was requested, the following was obtained: was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? suture was ¿falling apart¿ during use.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).Scrub tech (b)(6).Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Shipped out today (remaining sutures obtained yesterday).Tracking # (b)(4).
Additional Manufacturer Narrative
(b)(4).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.Additional h6 component code: g07002 no device problem found.Investigation summary: the product was returned to ethicon for evaluation.Nine representative unopened samples were received for analysis.Product code pdp316h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, 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 the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and suture was used.During the procedure, it was reported to the sales rep that the facility is having issue with the product.It was breaking apart as per new additional information received.Unknown number of sterile samples returning.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4) h6 component code: g07002 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained via: was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Awaiting the remainder of the sutures in the lot number.(b)(6), supply chain, stated that dr.(b)(6).(plastic surgeon) said it was ¿breaking apart¿.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.

• 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: 20267816
• Report Number: 2210968-2024-10096
• Device Sequence Number: 17020449
• Product Code: NEW
• UDI-Device Identifier: 10705031048027
• UDI-Public: (01)10705031048027(17)290131(10)UBMLMT
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2024

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 Catalogue Number: PDP316H
• Device Lot Number: UBMLMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 10/17/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/04/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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