MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 G/W; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9306
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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 an aortic root replacement procedure on (b)(6) 2018 and suture was used.The needle tip was broken when it was removed from the package the device was not used on the patient.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: 0(b)(4) 2018.A needle-suture piece, a needle-suture combination, and empty opened overwrap packets were received for analysis.The product is multi-strand and double armed per packet.During the visual inspection of the needle-suture piece, the swage and attachment area were as expected; however, the tip of the needle was broken, and slight marks were observed on the body of the needle which appears to be from use of the surgical instrument.Additionally, the suture piece was examined, body fluids were found, and the end was cut.Marks were observed on the tip area of the needle.The failed suture needle was submitted for fractographic evaluation to assess the fracture failure mode.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.This was a ductile fracture.The needles-suture combination was examined for visual inspection and no defects, needle breakage or tip defect were observed.The tips of the needles were as expected.The resistance test was performed, and no issues or anomalies were noted.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, (needle-suture piece) needle breakage was found.Per the sample condition of the needle-suture combination, no breakage needle was observed.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 G/W
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7763987
• Report Number: 2210968-2018-75012
• Device Sequence Number: 16445123
• Product Code: GAT
• UDI-Device Identifier: 10705031032668
• UDI-Public: 10705031032668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/18/2018

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: 04/30/2022
• Device Catalogue Number: D9306
• Device Lot Number: LEZ787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/26/2018
• Patient Sequence Number: 1