MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL MONOCRYL+; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B408
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Procedure name? what layer of tissue was being used or closed? was the end-user a new user of this product? what do you mean by " suture is not barbed" ? was this noticed during use on patient while suturing where barbs do not engage leading to suture slippage (non-engagement) in tissue? or was this noticed before use on patient, while in package or during dispensing?.
Event or Problem Description
It was reported that the patient underwent a colon surgical procedure on an unknown date and barbed suture was used.During the procedure, it was found that the suture was not barbed.Another device was used to complete the procedure.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.Additional summary: the actual device and unopened representative samples were returned for analysis.During the visual inspection of the opened sample, the swage and attachment area were as expected.However, ten barbs were measured and didn¿t met the minimal depth requirement resulting in a smaller barb.  in the visual inspection of unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area were as expected.Although the review of the barbs, samples were out of the minimal depth requirement.The rest of the samples were opened and have the same condition.   per the samples condition, the assignable cause is barb depth out of specification.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/30/2019.Corrected information: investigation summary: it was reported barb non-engagement in tissue.  a dispensed needle-suture combination and twenty unopened samples of product code sxmp1b408, lot llh607 were returned for analysis.  during the visual inspection of the opened sample, the swage and attachment area were noted to be as expected.The suture was inspected along of the strand and no defects were found.Also, ten barbs were measured, and all barbs met with the requirements.In addition, the loops were as expected.  in the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area of the needles were noted to be as expected.The sutures were inspected along of the strand and no defects were found.Also, ten barbs were measured, and all barbs met with the requirements.In addition, the loops were as expected.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the samples condition, no barb non-engagement in tissue was found.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2018-74482, 2210968-2018-74484, 2210968-2018-74485, analysis results have been included in follow-up reports for each.

• Brand Name: STRATAFIX SPIRAL MONOCRYL+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7699185
• Report Number: 2210968-2018-74482
• Device Sequence Number: 19237194
• Product Code: GAM
• UDI-Device Identifier: 10705031236356
• UDI-Public: 10705031236356
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: SXMP1B408
• Device Lot Number: LLH607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 04/04/2019
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/05/2018; 04/30/2019
• Patient Sequence Number: 1