MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 2-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	C012D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been 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 a patient underwent aortic valve replacement on (b)(6) 2019 and suture was used.The needle-suture was used for lifting the pericardium.After suturing, it was found that the needle tip had been broken off.The broken piece of needle tip was found with no problem.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional evaluation summary: the actual sample was returned for evaluation.A fracture was observed in the body near the tip 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 evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.There is no evidence of any material flaw that would cause premature failure.

• Brand Name: SILK SUTURE 18"(45CM) 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: 8327054
• Report Number: 2210968-2019-78810
• Device Sequence Number: 11209948
• Product Code: GAP
• UDI-Device Identifier: 10705031023390
• UDI-Public: 10705031023390
• 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): 01/16/2019

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: 08/31/2023
• Device Catalogue Number: C012D
• Device Lot Number: MKH876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/15/2019
• Patient Sequence Number: 1