MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 0 S/A FSL; SUTURE, NONABSORBABLE, SILK

Model Number	680H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020, and suture was used.During the procedure, the tip of the needle broke.The tip of needle was retrieved by the physician.The device is not available for return.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/16/2020.Additional h6 component code: g07002 device not returned.A manufacturing record evaluation was performed for the finished device batch pch976, 680h56 and no non-conformances were identified.This medwatch report is in response to receipt of user facility medwatch report mw# 5096403.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected b5 narrative: it was reported via user facility medwatch report mw# 5096403 that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the tip of the needle broke.The tip of needle was retrieved by the physician.The device is not available for return.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: SILK BLK 30IN 0 S/A FSL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10692279
• Report Number: 2210968-2020-08084
• Device Sequence Number: 2836556
• Product Code: GAP
• UDI-Device Identifier: 10705031008106
• UDI-Public: 10705031008106
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 02/29/2024
• Device Model Number: 680H
• Device Catalogue Number: 680H
• Device Lot Number: PCH976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1