MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 0 S/A CTXB; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: a labeled winding former, a dispensed needle/suture were returned for analysis.During the visual inspection of sample, the swage and attachment area were noted to be as expected.There were slight marks on the body of the needle which appeared to be by the use of a surgical instrument.The suture was examined and body fluids on barbs were observed; damage near end was noted.However, the two sides of the fixation tab were broken.The manufacturing records were reviewed and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the sample condition of the received needle-suture, the assignable cause of the fixation feature breakage is suggested as an improper handling of the sample.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular procedure on an unknown date and a barbed suture was used.During surgery, the fixation tab broke.Upon evaluation of the returned sample it was found that the two sides of the fixation tab were broken.There were no adverse patient consequences reported.

• Brand Name: SFX SYM PDS+ VIO 18IN 0 S/A CTXB
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8253169
• Report Number: 2210968-2019-78441
• Device Sequence Number: 11158676
• Product Code: NEW
• UDI-Device Identifier: 10705031227651
• UDI-Public: 10705031227651
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• 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): 12/21/2018

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 Expiration Date: 02/29/2020
• Device Catalogue Number: SXPP1A302
• Device Lot Number: MCK206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/16/2019
• Patient Sequence Number: 1