MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 6-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	706G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
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 that a patient underwent a ptosis procedure on (b)(6) 2018 and suture was used.During use, the needle popped off without any tension.Case completed with another device of the same product code.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/17/2018.Investigation summary: it was reported performance pull off suture needle.A empty folder, a dispensed needle suture and a detached needle were received for analysis.This product code is double armed.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole was examined under 20x magnification and remnant suture was noted.The suture end is severely cut (damaged), resulting in a clip off defect.In the inspection of the needle/suture combination, the swage and attachment area were as expected.The manufacturing records couldn't be reviewed as the batch number is unknown.Per the sample condition the assignable cause of the needle pull off, is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: SILK SUTURE 18"(45CM) 6-0 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: 8094220
• Report Number: 2210968-2018-77283
• Device Sequence Number: 16830553
• Product Code: GAP
• UDI-Device Identifier: 10705031008724
• UDI-Public: 10705031008724
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/26/2018

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: 706G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/17/2018
• Patient Sequence Number: 1