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	12/13/2018
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.
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on (b)(6) 2018 and barbed suture was used.The suture broke during reverse stitch.Another like device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).An empty opened foil, a paper lid, a winding former with eight parked needle/suture combinations of product were returned for analysis.A needle/suture piece and a suture piece were returned for analysis.During the visual inspection of sample, there were body fluids on strands, and a dent in the middle of strands and on the ends; also, the ends were damaged (cut).Besides, the barbs near to the end were damaged.Due to condition of the sample received no functional test could be performed.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the sample condition, the assignable of the suture breakage is suggested as an improper handling of the sample.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• 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 0151
• MDR Report Key: 8232767
• Report Number: 2210968-2019-78297
• Device Sequence Number: 13518634
• Product Code: NEW
• UDI-Device Identifier: 10705031245112
• UDI-Public: 10705031245112
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup,Followup
• Report Date (Section B): 12/14/2018

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 Catalogue Number: SXPP1A446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/15/2019; 02/15/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/15/2019; 02/15/2019
• Patient Sequence Number: 1