MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1629H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
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.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.Did the needle break into two separate pieces? did the needle pull off from the suture? when did the event occur (while in the package / during dispensing / during preparation / during use)? what is the lot number?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the needle tore itself from the suture.It was unknown if there were any patient consequences and no adverse patient consequences were reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and the following was obtained: 1.Did the needle break into two separate pieces? no, 2.Did the needle pull off from the suture? yes, 3.When did the event occur (while in the package / during dispensing / during preparation / during use)? n/a, 4.What is the lot number? unknown.

• Brand Name: ETHILON SUTURE 18"(45CM) 4-0 BLK
• 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: 8350614
• Report Number: 2210968-2019-78936
• Device Sequence Number: 16632790
• Product Code: GAR
• UDI-Device Identifier: 10705031001435
• UDI-Public: 10705031001435
• Combination Product (Y/N): N
• 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): 01/21/2019

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 Catalogue Number: 1629H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1