MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 27IN 3-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B423
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested: please explain; what was the specific issue with the device? was the procedure completed successfully? was there any adverse consequence associated with the patient? name of the procedure? date the event occurred? lot number.Initial procedure date? what is the patient¿s current health status and condition? the following information was obtained: in response to the question regarding the complaint below.Stratafix spiral suture breaks to easy when it is being used in robotic ventral hernia repair.Dr.Wilcox has used the suture in a number of his cases and feels that the suture breaks at a higher rate than the competitive suture he used before stratafix.The procedure was not completed effectively with the ethicon products available.Stratafix spiral fails to grasp an hold the tissue as effectively as our competitive sutures.The surgeon needs to pull harder on the suture to get it to hold.The surgeon doesn't feel the barbs are pronounced enough to hold the tissue or the mesh in tact.Their are no patient consequences as a result of the suture.Patient is fine an healing well.The surgeon used vloc to complete the case after the stratafix suture broke.Note: events reported in 2210968-2020-00548, 2210968-2020-00561, 2210968-2020-00562, and 2210968-2020-00563.
Event or Problem Description
It was reported that a patient underwent a robotic ventral hernia repair procedure on an unknown date and a barbed suture was used.During the procedure, the suture broke too easy when using.The suture did not have barbs that are strong enough to hold the tissue together so the surgeon had to pull harder to approximate the tissue.Eventually it broke when pulled on it long enough.A different device was used to complete the procedure.There were no adverse patient consequences.No additional information was provided.

• Brand Name: SFX SPI PDS+ UNI VIO 27IN 3-0 S/A RB-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: 9612901
• Report Number: 2210968-2020-00547
• Device Sequence Number: 11366859
• Product Code: NEW
• UDI-Device Identifier: 10705031235946
• UDI-Public: 10705031235946
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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: SXPP1B423
• Device Catalogue Number: SXPP1B423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1