MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 6-0 S/A C-1; SUTURE, NONABSORBABLE, SILK

Catalog Number	707G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a mouse underwent a coronary ligation on an unknown date and suture was used.During the procedure, the suture was brittle and prone to break, even with a slight force.It was unknown how case was completed.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Investigation summary: it was reported performance breakage suture.Two sealed boxes and an opened box with nine unopened samples were received for analysis.The issue sample was not returned for evaluation and each box contains 12 samples.As total of thirty-three samples.During the visual inspection of thirteen 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 of the strand and no defects, damaged or suture breakage were noted.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 breakage suture was found and the tested samples met the finished goods requirements.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.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.

• Brand Name: SILK BLK 18IN 6-0 S/A C-1
• 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: 8271702
• Report Number: 2210968-2019-78557
• Device Sequence Number: 16506097
• Product Code: GAP
• UDI-Device Identifier: 10705031008779
• UDI-Public: 10705031008779
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 03/31/2023
• Device Catalogue Number: 707G
• Device Lot Number: MDM998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/19/2019
• Patient Sequence Number: 1