MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 6IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A413
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.A manufacturing record evaluation was performed for the finished device me5019 number, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a robotic inguinal hernia procedure on an unknown date in 2019 and barbed suture was used.The needle popped off the suture during closure of the peritoneum.The needle was retrieved from the patient.The case was completed with another like device.There were no adverse patient consequences reported.

• Brand Name: STFX SYM PDS+ UNI VIO 6IN 3-0 S/A SH
• 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: 8412635
• Report Number: 2210968-2019-79392
• Device Sequence Number: 16695763
• Product Code: NEW
• UDI-Device Identifier: 10705031245044
• UDI-Public: 10705031245044
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 04/30/2020
• Device Catalogue Number: SXPP1A413
• Device Lot Number: ME5019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/12/2019
• Patient Sequence Number: 1