MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 4-0 S/A PC-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1864G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.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.Was the needle tip removed during the initial procedure? does the needle tip remain in the patient at the current time? were there any adverse patient consequences?.
Event or Problem Description
It was reported that a patient underwent a reconstructive skin surgery on (b)(6) 2018 and suture was used.During the procedure, the tip of needle broke off during suturing.The procedure was completed.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/11/2019.Additional information was requested and the following was obtained: was the needle tip removed during the initial procedure? yes it was removed during the procedure.Does the needle tip remain in the patient at the current time? no it was removed.Were there any adverse patient consequences? not according to the surgeon.

• Brand Name: ETHLN BLK 18IN 4-0 S/A PC-3 PRM MP
• 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: 8004361
• Report Number: 2210968-2018-76768
• Device Sequence Number: 1311226
• Product Code: GAR
• UDI-Device Identifier: 10705031002814
• UDI-Public: 10705031002814
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 09/28/2018

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: 12/31/2022
• Device Catalogue Number: 1864G
• Device Lot Number: MAH695
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1