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

Catalog Number	689G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no unexpected outcomes or complications.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.No altered treatment.Any other adverse patient consequences and what treatment was provided to manage them? no other adverse patient consequences.Lot number? kje586.
Event or Problem Description
It was reported that the patient underwent septoplasty procedure on (b)(6) 2019 and suture was used.While the surgeon was closing in the nose, the tip of the needle broke off the suture.The tip of the needle was observed and retrieved and disposed of in the sharps container.The procedure was delayed due the event and was completed successfully.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: ETHILON SUTURE 18"(45CM) 6-0 CLR
• 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: 8550177
• Report Number: 2210968-2019-80637
• Device Sequence Number: 13553270
• Product Code: GAR
• UDI-Device Identifier: 10705031008366
• UDI-Public: 10705031008366
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/27/2019

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: 07/31/2021
• Device Catalogue Number: 689G
• Device Lot Number: KJE586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1