MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	K832H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a gastric bypass procedure on (b)(6) 2018 and suture was used.During the procedure, the needle broke in half while suturing.It is unknown how the case was completed.There were no patient consequences reported.No additional information was provided.

• Brand Name: SILK SUTURE 30"(75CM) 3-0 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: 7710177
• Report Number: 2210968-2018-74535
• Device Sequence Number: 2643390
• Product Code: GAP
• UDI-Device Identifier: 10705031044364
• UDI-Public: 10705031044364
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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 Catalogue Number: K832H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/23/2018
• Patient Sequence Number: 1