MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 2-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C012D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: (b)(4) device not returned.This medwatch report is in response to receipt of maude event report mw5102332.
Event or Problem Description
It was reported that a patient underwent a planned parotidectomy with facial nerve dissection and preservation in (b)(6) 2021 and suture was used.During the procedure, a needle tip (1 mm) was noted to have broken off.The wound was explored without success, but radiograph confirmed presence.The surgeon determined the risk outweighed the benefit of removal.There were no patient consequences reported.No further information is available.

• Brand Name: SILK SUTURE 18"(45CM) 2-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12366510
• Report Number: 2210968-2021-07680
• Device Sequence Number: 4633128
• Product Code: GAP
• UDI-Device Identifier: 10705031023390
• UDI-Public: 10705031023390
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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 Model Number: C012D
• Device Catalogue Number: C012D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1