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

Catalog Number SXPP1B409

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2018

Event Type  malfunction  

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.

Event Description

It was reported that a patient underwent a laparoscopic vaginal hysterectomy on (b)(6) 2018 and barbed suture was used.It was noticed that the barbs are no longer pronounced enough to keep the suture in place and there are no barbs from approximately 1¿ from the swage of the needle distally.Two strands of the barbed suture were used to overlap sufficiently to get a good locking stitch.No adverse patient consequences were reported.

Manufacturer Narrative

Product complaint # pc-(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary two empty open foils, two empty winding former two dispensed needle suture combinations, a needle suture piece and three unopened samples of product code (b)(4) , lot mdq792 were returned for analysis during the visual inspection of a needle/suture piece, the swage and attachment area were noted to be as expected and the end suture was cut that appears to be by use of surgical instrument.Also, body fluids were observed and the functional test (measured barbs) cannot be performed.During the visual inspection of five samples (two open and three unopened), the swage and attachment area were noted to be as expected, loops and the barbs were present on the strands.Ten barbs were measured in each sample and was noted a minimal depth, resulting in a smaller barb.No other defects were found.The barb to center of loop and first barb to end of needle barrel were inspected, and no barbs were noted, and this condition is correct according to ethicon requirements.According to condition of the needle-suture piece, the assignable cause of barb non engagement in tissue could not be determined.Due to the condition of five samples, the evaluation found that the barb depth was out of specification.The information provided is compiled monitored and reviewed on a routine basis for any associated trends.

Manufacturer Narrative

(b)(4).Corrected device evaluated by mfr: five samples with lot # mdq792 were received for analysis.During the visual inspection, all barbs meet the specification requirement.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this batch.According to the samples conditions, the samples met the finish goods requirements.Corrected information: adverse event problem.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2018-76178, 2210968-2018-76173.Analysis results have been included in follow-up reports for each.

• 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7933552
• MDR Text Key: 122634337
• Report Number: 2210968-2018-76289
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236127
• UDI-Public: 10705031236127
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018

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: 03/31/2020
• Device Catalogue Number: SXPP1B409
• Device Lot Number: MDQ792
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 09/07/2018; 11/20/2018
• Supplement Dates FDA Received: 11/01/2018; 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1