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

Catalog Number SXPP1B409

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent to the fda: 02/17/2017.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: was the procedure a lap.Hysterectomy? yes.Was it a robotic procedure? no.Was the product code same? yes.Was the surgeon same? yes.Was the user experienced? another device? experienced user of pdo version.Provide lot number if available unknown.

Event Description

It was reported that the patient underwent a laparoscopic hysterectomy on (b)(6) 2017 and the barbed suture was used.During the procedure, the suture is backing out of tissue; not holding tension.The doctor opined that barbs are less aggressive.Other interrupted suture was used to complete the procedure.There were no patient consequences reported.

• Brand Name: STRATAFIX SPIRAL PDS PLUS
• 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; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6341060
• MDR Text Key: 67823092
• Report Number: 2210968-2017-30782
• Device Sequence Number: 1
• Product Code: NEW
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1B409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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