MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number SXPP1B420

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 Description

It was reported that a patient underwent a colo-rectal procedure on (b)(6) 2018 and a barbed suture was used.During the procedure, the thread did not hold.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.

• Brand Name: STRATAFIX SPIRAL PDS+
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7534198
• MDR Text Key: 108991912
• Report Number: 2210968-2018-72966
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031235809
• UDI-Public: 10705031235809
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: SXPP1B420
• Device Lot Number: LEP974
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/22/2018
• Date Device Manufactured: 05/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1