MAUDE Adverse Event Report: ETHICON INC. MERSILENE SUTURE 36"(90CM) 5MM WHT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9212
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(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.Additional information was requested and the following was obtained: when did the needle pull off (while in the package / during dispensing / during preparation / during use)? during use.What is the lot number(s)? lot number is: mdh105.
Event or Problem Description
It was reported that a patient underwent a total hip procedure on (b)(6) 2018 and suture was used.During the procedure, the suture popped off the needle at the swage.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/05/2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: MERSILENE SUTURE 36"(90CM) 5MM WHT
• 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: 8084319
• Report Number: 2210968-2018-77230
• Device Sequence Number: 19232220
• Product Code: GAT
• UDI-Device Identifier: 10705031032422
• UDI-Public: 10705031032422
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/24/2018

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 Expiration Date: 03/31/2023
• Device Catalogue Number: D9212
• Device Lot Number: MDH105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/05/2018
• Patient Sequence Number: 1