MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 2-0 S/A UR-6; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B419
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 10/21/2020.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested, but unavailable: what tissue was being approximated or sutured when it broke? on the skin.What is the specific number of devices (total qty involved) of stratafix that were suture broken during this procedure? since quantity of product involved is 4.The sales rep reported 4 devices.Lot number? no further information is available.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular surgery on (b)(6) 2020 and barbed suture was used.During the procedure, when closing the chest, the suture broke.The lot number is unknown.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 2-0 S/A UR-6
• 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: 10712846
• Report Number: 2210968-2020-08183
• Device Sequence Number: 3482944
• Product Code: NEW
• UDI-Device Identifier: 10705031235915
• UDI-Public: 10705031235915
• Combination Product (Y/N): N
• PMA/510(K) Number: K150670
• 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
• Report Date (Section B): 10/06/2020

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 Model Number: SXPP1B419
• Device Catalogue Number: SXPP1B419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1