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

Catalog Number	K834H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
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.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.What is the number of sutures that frayed during the procedure? what is the number of sutures that broke during the procedure?.
Event or Problem Description
It was reported that a patient underwent a nissen procedure on (b)(6) 2018 and suture was used.During the procedure the suture frayed and broke while being pulled through the tissue.Procedure was completed with another suture of the same product code from a different lot.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).
Additional Manufacturer Narrative
Samples of same lot returned and evaluated.No defects were found on the package.The sample was opened and the swage and attachment area were as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage was observed.The sample was tested by knot tensile strength and the result was above the minimum individual strength requirement.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• 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 0151
• MDR Report Key: 7380518
• Report Number: 2210968-2018-71735
• Device Sequence Number: 1273539
• Product Code: GAP
• UDI-Device Identifier: 10705031044418
• UDI-Public: 10705031044418
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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): 03/12/2018

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 Catalogue Number: K834H
• Device Lot Number: KBQ081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018; 04/16/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 03/29/2018; 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1