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

Model Number	SXPP1B401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mmq138, 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 an unknown procedure on an unknown date and a barbed suture was used.During the procedure, the loop broke.A new suture was opened.There were no adverse patient consequences reported.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
• MDR Report Key: 10784533
• Report Number: 2210968-2020-08563
• Device Sequence Number: 4134989
• Product Code: NEW
• UDI-Device Identifier: 10705031236042
• UDI-Public: 10705031236042
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182873
• 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): 08/07/2019

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 Model Number: SXPP1B401
• 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: 08/07/2019
• Initial Report FDA Received Date: 11/04/2020
• Patient Sequence Number: 1