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

Model Number	M104T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.A manufacturing record evaluation was performed for the finished device batch number qemdtm, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an craniotomy surgery on (b)(6) 2020 and suture was used.During the procedure, the needle tip was broken easily during dural suturing.There were no adverse patient consequences reported.No additional information was provided.

• 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: 10979467
• Report Number: 2210968-2020-09795
• Device Sequence Number: 19078204
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: No Information
• Device Expiration Date: 04/30/2025
• Device Model Number: M104T
• Device Catalogue Number: M104T
• Device Lot Number: QEMDTM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1