MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number 2810G

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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: what is the procedure name and date? =>no further information is available.Please provide lot number =>no further information is available.No further information will be provided.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and the suture was used.During surgery, the suture was broken during use.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 07/31/2020.Additional events have been submitted via 2210968-2020-05623, 2210968-2020-05624, 2210968-2020-05625, 2210968-2020-05626, 2210968-2020-05627, 2210968-2020-05628, 2210968-2020-05629, 2210968-2020-05630, 2210968-2020-05631, and 2210968-2020-05632.Additional information was requested and the following was obtained: *how many devices were involved in this single procedure? *did the event occur during one or multiple patient procedures? *what are the procedure name and date? *please provide lot number.Suture breakage occurred with more than 6 needle-sutures.[lot number] unknown => pkb757.[qty to be returned] 7 => 10.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 09/18/2020.Representative samples returned to support investigation of multiple device issues captured in reports 2210968-2020-05623, 2210968-2020-05624, 2210968-2020-05625, 2210968-2020-05626, 2210968-2020-05627, 2210968-2020-05628, 2210968-2020-05629, 2210968-2020-05630, 2210968-2020-05631.Analysis results have been included in follow-up reports for each.Unopened samples of product were returned for analysis.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand with no defects, damage or suture breakage observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no suture breakage was found and the tested samples met the finished goods requirements.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ETHILON SUTURE 5"(13CM) 10-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10335125
• MDR Text Key: 200693353
• Report Number: 2210968-2020-05632
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031003972
• UDI-Public: 10705031003972
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2810G
• Device Catalogue Number: 2810G
• Device Lot Number: PKB757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Patient Sequence Number: 1