MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	424H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the suture broke.It was not reported how the procedure was completed.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Representative samples were returned for evaluation.They were visually and functionally examined for tensile strength and they met the requirements.

• Brand Name: SILK SUTURE 30"(75CM) 0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7449778
• Report Number: 2210968-2018-72226
• Device Sequence Number: 16434308
• Product Code: GAP
• UDI-Device Identifier: 10705031005327
• UDI-Public: 10705031005327
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2018

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: 10/31/2021
• Device Catalogue Number: 424H
• Device Lot Number: KMH602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 04/12/2018; 05/10/2018
• Initial Report FDA Received Date: 04/22/2018
• Supplement Report FDA Received Date: 05/09/2018; 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1