MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 12IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1A435
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).A manufacturing record evaluation was performed for the finished device phk550 batch number, and no non-conformance's were identified.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a robotic ventral hernia repair on (b)(6) 2020 and the barbed suture was used.After taking the barbed suture out of the abdomen, the nurse saw that the barbed suture was fraying near the swage, where the needle meets the suture.It looked like there were two separated sutures from the needle to where the first barb started.The procedure was completed successfully with no patient consequences and no delay.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 08/26/2020.Additional information: h3 evaluation: two pictures were provided for analysis.Upon visual inspection of the pictures, one needle-suture piece appears to be split; however, no conclusion could be reach as to what may have caused the reported incident since the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.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, 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.

• Brand Name: STFX SYM PDS+ UNI VIO 12IN 1 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10359578
• Report Number: 2210968-2020-05817
• Device Sequence Number: 14109326
• Product Code: NEW
• UDI-Device Identifier: 10705031245211
• UDI-Public: 10705031245211
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 06/30/2021
• Device Model Number: SXPP1A435
• Device Catalogue Number: SXPP1A435
• Device Lot Number: PHK550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1