MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CT; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A405

Device Problems Nonstandard Device (1420); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Additional information was requested and the following was obtained: *what was the specific issue with the stratafix symmetric pds plus tab? the specific problem is that the tab of the sfx symmetric pds plus was the half of the std.*please confirm the number of devices that had suture diameter issue along with the tab anomaly as mentioned in the reported event.The doctor was not sure, but he thank at least two devices *are there any photos available for visual analysis? asked to the surgeon *name of the procedure? the closure of uterus *initial procedure date? (b)(6) 2019, *date the event occurred? (b)(6) 2019.

Event Description

It was reported that the patient underwent closure of the uterus on (b)(6) 2019 and barbed suture was used.It was reported it was not possible to use the suture because the last part of the suture was thinner than standard and the tab of the barbed suture was half standard size.Consequently the suture could not exercise self-locking action.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device pam590 batch number, and no non-conformances were identified.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9492052
• MDR Text Key: 198499029
• Report Number: 2210968-2019-91102
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227682
• UDI-Public: 10705031227682
• Combination Product (y/n): N
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: SXPP1A405
• Device Catalogue Number: SXPP1A405
• Device Lot Number: PAM590
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/25/2020
• Patient Sequence Number: 1