MAUDE Adverse Event Report: ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 D/A V-5 8PLGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	SXX50
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported a patient underwent a valve surgery on (b)(6) 2019, and suture was used.During the procedure, the suture pulled off the needle.Changed to another suture to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/15/2019.Additional h3 investigation summary: an empty msda folder of product code sxx50 was received for evaluation.No needles or sutures were returned for evaluation to determine the assignable cause of the pull off suture needle.

• Brand Name: EB EXC 4GRN/4WHT 30IN 2-0 D/A V-5 8PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8789990
• Report Number: 2210968-2019-84275
• Device Sequence Number: 16620575
• Product Code: GAT
• UDI-Device Identifier: 10705031050693
• UDI-Public: 10705031050693
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/20/2019

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: SXX50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/15/2019
• Patient Sequence Number: 1