MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2870G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Evaluation: top folders of product were received for analysis.As needle or suture were not returned for evaluation further investigation could not be conducted.
Event or Problem Description
It was reported that a patient underwent a moyamoya procedure in (b)(6) of 2020 and the suture was used.It was reported that during surgery the needle popped off the suture.The needle was located and there was no patient consequence.

• Brand Name: ETHILON SUTURE 5"(13CM) 10-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9732733
• Report Number: 2210968-2020-01318
• Device Sequence Number: 3108186
• Product Code: GAR
• UDI-Device Identifier: 10705031004160
• UDI-Public: 10705031004160
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: 08/31/2024
• Device Model Number: 2870G
• Device Catalogue Number: 2870G
• Device Lot Number: PKM920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/20/2020
• Patient Sequence Number: 1