MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A BB; SUTURE, SURGICAL, ABSORBABLE

Model Number	D8350
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Attempts are being made to receive a device for evaluation.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: was the surgery completed successfully? no further information is available.What is the current condition of the patient? no further information is available.What was used to complete the procedure? no further information is available.How many of the total quantity were actually involved for the reported issue? no further information is available.2nd device return follow up.We regularly contact with sales rep about the device returning.No further information will be provided.
Event or Problem Description
It was reported that the patient underwent an unknown chest/thoracic surgery on (b)(6) 2020 and the suture was used.During the procedure, the suture was broken during use in the thoracic cavity.There were no patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/22/2020.Additional information received: the suture was detached from the needle easily.It was not a control release needle.The suture was not broken.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 5/13/2020 additional information: d10, h4 additional h3 investigation summary: it was reported pull off - suture needle.One empty open labeled winding former and a needle of product code d8350, lot phk651 was received for analysis.During the visual inspection of the needle, the swage and attachment area were as expected and remnant of the suture was noted into the barrel hole and marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.In addition, the suture was not returned for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable of the performance pull off suture needle, suggest an improper handling of the sample.Additional h3 investigation summary: it was reported pull off - suture needle.Unopened samples of product code d8350, lot phk651 were received for analysis.During the visual inspection of the samples, no defects were found on the packages.The samples 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PDSII VIO 27IN 4-0 S/A BB
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9900297
• Report Number: 2210968-2020-02452
• Device Sequence Number: 16738653
• Product Code: NEW
• UDI-Device Identifier: 10705031029941
• UDI-Public: 10705031029941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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: 06/30/2024
• Device Model Number: D8350
• Device Catalogue Number: D8350
• Device Lot Number: PHK651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 05/08/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/22/2020; 05/13/2020
• Patient Sequence Number: 1