MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 27IN 2 S/A CTX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent a total knee replacement on (b)(6) 2019 and a barbed suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.

• Brand Name: STFX SPI PDS+ UNI VIO 27IN 2 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8606200
• Report Number: 2210968-2019-81306
• Device Sequence Number: 14210575
• Product Code: NEW
• UDI-Device Identifier: 10705031236042
• UDI-Public: 10705031236042
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/16/2019

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 Expiration Date: 10/31/2020
• Device Catalogue Number: SXPP1B401
• Device Lot Number: MMQ138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1