MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A400

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

Event Description

It was reported that a patient underwent a c-section on (b)(6) 2016 and barbed suture was used to close the fascia.After a day while the patient is still hospitalized, her bowel was coming out from her belly.The patient underwent a second surgery.During the second surgery the surgeon found that the fascia was 2/3rd open and the suture was released.The part that was open was the beginning of the suture, the part with the fixation tab.At this time the fascia was closed with a different type of suture.The patient is ok and feeling well.It appears that the cause of this was the technique and not the product.The surgeon didn¿t perform the anchoring and tab-lock of the suture based on the ifu and therefore the suture failed to approximate the fascia.No additional information was provided.

Manufacturer Narrative

Representative samples were received for evaluation.Visual inspection was performed and samples were examined along the strands and no defects or fixation feature breakage was observed.The samples were functionally tested for strength and met the requirements.

• Brand Name: STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6247641
• MDR Text Key: 64689717
• Report Number: 2210968-2017-30192
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K113004
• 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,Followup
• Report Date: 01/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: SXPP1A400
• Device Lot Number: KGK483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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
• Patient Outcome(s): Required Intervention