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

Catalog Number SXPP1B414

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

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 gastropexy procedure on (b)(6) 2018 and a barbed suture was used.During the procedure, the suture was not holding and was sliding backwards through the tissue.Another device was used to complete the procedure.There were no adverse consequences for the patient.No additional information was available.

Manufacturer Narrative

(b)(4) date sent to the fda: 09/19/2018 additional narrative: the procedure occurred in a dog.A different device was used to complete the procedure.

• 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 PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7845354
• MDR Text Key: 119153010
• Report Number: 2210968-2018-75614
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031235878
• UDI-Public: 10705031235878
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: SXPP1B414
• Device Lot Number: LAH358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1