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

Model Number	K834H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2019 and suture was used.It was reported that the suture broke when trying to perform the knotting.The surgeon used more threads than usual.There were no adverse patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/29/2020.A manufacturing record evaluation was performed for the finished device lot al8307, and no non-conformances were identified.Additional h3 investigation summary: it was reported breakage suture.One needle-suture piece of product code k834, lot al8307 was received for analysis.During the visual inspection of the opened sample, the swage and attachment area were noted to be as expected.However, marks on the body needle and the end of the suture piece cut that appears to be by the use of a surgical instrument could be observed.The other section of the suture was not returned for analysis.Additionally, a functional test was performed and the tensile strength force was above the minimum requirement.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.Additional information was requested and the following was obtained: please provide the specific number of sutures that broke during this procedure.Customer confirmed there were 5 broken threads.Note: events reported in 2210968-2019-89406, 2210968-2019-89410, 2210968-2019-89414, 2210968-2019-89415 and 2210968-2020-00788.

• Brand Name: SILK SUTURE 30"(75CM) 0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9268744
• Report Number: 2210968-2019-89414
• Device Sequence Number: 2497904
• Product Code: GAP
• UDI-Device Identifier: 10705031044418
• UDI-Public: 10705031044418
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 10/07/2019

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: No Information
• Device Expiration Date: 01/31/2024
• Device Model Number: K834H
• Device Catalogue Number: K834H
• Device Lot Number: AL8307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/29/2020
• Patient Sequence Number: 1