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

Catalog Number SXPP1A400

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problems Wound Dehiscence (1154); Pain (1994); Discharge (2225); No Code Available (3191)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: kpz114, klm496, jpz232 and kkm702.Additional information was requested and the following was obtained: was the end-user a new user of this product? no.If there was any patient impact (additional treatment required etc.) and/or problem (prolonged surgery etc.) due to the non-conformance reported? yes the patient was re-operated to close the abdominal cavity.Did they have formal training on the use of these devices? yes.Was the sales rep present during the procedure? no.Are there sterile samples from the reported finished goods lot available for testing? yes.The initial c-section surgery occurred on (b)(6).On (b)(6), after 3 days the patient was complaining about pain, cirrhotic discharge and was diagnosed with external outpouring for the intestine, she was sent back to the operating room.During the revision surgery it was identified the stratafix pds used to seal the fascia was loosen/torn and the fixation loop was missing.The used suture was saved and will be sent for investigation.The hospital couldn¿t retrieve the lot number of the product that was used however, they did provide a picture of all the products they found in the operating room inventory.A used suture piece with an unknown lot number was returned for evaluation.During the visual inspection of the suture piece it was noted that some barbs presented degradation and damaged due to the use and exposure to the environment.In addition, the sides of the fixation tab were noted to be broken off the nucleus of the tab.As the device is absorbable and the time of exposition to the environment cannot be determined, no additional test could be performed due to the condition of the sample received.During the visual inspection of the representative sample, no defects were found on the package.According to the sample condition no suture breakage or damaged on the fixation tab was observed and the suture tested met the finished good requirements.

Event Description

It was reported that the patient underwent a c-section procedure on (b)(6)2017 and the barbed suture was used to close the fascia.Three days after the procedure, the patient was complaining about pain, cirrhotic discharge and was diagnosed with external outpouring for the intestine, she was sent back to the operating room.During the revision surgery it was identified the barbed suture was loosen/torn and the fixation loop was missing.The patient was re-operated to close the abdominal cavity.No further information is available.

Manufacturer Narrative

A review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Lot kkm702; expiration date: 08/31/2018; date of mfg.: 09/07/2016 lot jpz232; expiration date: 11/30/2017; date of mfg.: 12/09/2015 lot klm496; expiration date: 09/30/2018; date of mfg.: 10/05/2016 lot kpz114; expiration date: 11/30/2018; date of mfg.: 12/13/2016.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6808859
• MDR Text Key: 83192682
• Report Number: 2210968-2017-33498
• 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: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1A400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: No
• 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