MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 2-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	423H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.
Event or Problem Description
It was reported that a patient underwent a hernia procedure on (b)(6) 2018 and a suture was used.During surgery the suture broke while knotting.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Pc-(b)(4).It was reported performance breakage suture.A needle-suture piece was returned for analysis.During the visual inspection of the sample (needle/suture piece), the swage and attachment area were as expected, and marks were observed on the body needle, and the end of the suture was observed busted.The other section of the suture was not returned for analysis.In addition, a functional test was performed and the tensile force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the condition of opened sample, the assignable cause of performance breakage suture, was suggests an improper handling of the sample.Two unopened samples were inspected visually, no defects were found on the packages.The samples were opened, and the swage and attachment area of needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile force were above the minimum requirements.Per the condition of the representative samples, no performance - breakage suture was found on the sutures and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 5 device issues captured in reports 2210968-2018-76158, 2210968-2018-76159, 2210968-2018-76160, 2210968-2018-76161, 2210968-2018-76162.Analysis results have been included in follow-up reports for each.

• Brand Name: SILK SUTURE 30"(75CM) 2-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7925524
• Report Number: 2210968-2018-76161
• Device Sequence Number: 13931708
• Product Code: GAP
• UDI-Device Identifier: 10705031005297
• UDI-Public: 10705031005297
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 06/30/2021
• Device Catalogue Number: 423H
• Device Lot Number: AF3811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/31/2018
• Patient Sequence Number: 1