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

Catalog Number	C012D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that the patient underwent an unknown cardiovascular procedure on unknown date and suture was used.The suture was detached from the needle.There were no adverse patient consequences reported.No additional information is available.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional evaluation summary: one empty opened overwrap packet, a paper lid and a winding former with seven needle-suture combination and a parked needle in slot #1 of product code c012d, lot pah974.The product code is control release and required eight strands per packet.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted and slightly marks were noted on the body needle.The suture was not present to determine the assignable cause.In the inspection of seven needle-suture combinations, the swage and attachment area were noted to be as expected and a functional test was performed and the pull force results meet the customer requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It could not be determined what may have caused the reported incident of suture detached from the needle.

• 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: 8746870
• Report Number: 2210968-2019-83461
• Device Sequence Number: 13875634
• 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): 06/06/2019

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: 12/31/2023
• Device Catalogue Number: C012D
• Device Lot Number: PAH974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/30/2019
• Supplement Report FDA Received Date: 08/06/2019
• Patient Sequence Number: 1