MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 9IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A446
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mlk504 batch number, 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 robotic hernia repair on (b)(6) 2019 and barbed suture was used.The suture broke during use.The procedure was completed with a like suture from a different lot with no patient consequences reported.No additional information available.

• Brand Name: STFX SYM PDS+ UNI VIO 9IN 0 S/A CT-2
• 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: 9297770
• Report Number: 2210968-2019-89746
• Device Sequence Number: 16670778
• Product Code: NEW
• UDI-Device Identifier: 10705031245112
• UDI-Public: 10705031245112
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 09/30/2020
• Device Catalogue Number: SXPP1A446
• Device Lot Number: MLK504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/08/2019
• Patient Sequence Number: 1