MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	F2413H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Reported lot 4kr824 is invalid.Please clarify the lot involved.
Event or Problem Description
It was reported that the patient underwent a dental surgery on (b)(6) 2019 and suture was used.During the procedure, the thread pulled off from the needle.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.Additional information was requested and the following was obtained: please clarify the lot involved.The lot number is mkr824.

• Brand Name: ETHILON SUTURE 30IN(75CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8470889
• Report Number: 2210968-2019-79862
• Device Sequence Number: 2014918
• Product Code: GAR
• UDI-Device Identifier: 10705031238916
• UDI-Public: 10705031238916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: F2413H
• Device Lot Number: MKR824
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1