MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 8-18" (45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	M104T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown neurosurgery procedure on (b)(6) 2020 and the suture was used.The suture was detached from the needle easily during suturing on the dura mater.It was not a control release needle.There were no patient consequences were reported.

• Brand Name: SILK SUTURE 8-18" (45CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9876708
• Report Number: 2210968-2020-02340
• Device Sequence Number: 11609116
• Product Code: GAP
• UDI-Device Identifier: 10705031045026
• UDI-Public: 10705031045026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/27/2020

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: 06/30/2024
• Device Model Number: M104T
• Device Catalogue Number: M104T
• Device Lot Number: PHZ997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/25/2020
• Patient Sequence Number: 1