MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 0 S/A V-34; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B404
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a hysterectomy four months ago and the barbed suture was used.After the surgery, the patient mentioned she felt something in her vagina.A piece of suture was not absorbed and loose in the vagina, and about three cm of perceived barbed suture was cut during post-op examination on july 8.It was also reported that it is uncertain if the patient removed a loose suture piece as it was un-intact, or the surgeon did in the office there were no patient consequences reported.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 0 S/A V-34
• 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: 10300049
• Report Number: 2210968-2020-05417
• Device Sequence Number: 2577308
• Product Code: NEW
• UDI-Device Identifier: 10705031236073
• UDI-Public: 10705031236073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150670
• 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): 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SXPP1B404
• Device Catalogue Number: SXPP1B404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1