MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 2-0 S/A PS PRM; SUTURE, NONABSORBABLE, SILK

Catalog Number	1588H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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 tip of the needle broke off.The case was completed with another device of the same product code.There were no patient consequences reported.No further information is available.

• Brand Name: SILK BLK 18IN 2-0 S/A PS PRM
• 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: 8219368
• Report Number: 2210968-2019-78194
• Device Sequence Number: 334712
• Product Code: GAP
• UDI-Device Identifier: 10705031001367
• UDI-Public: 10705031001367
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: No Information
• Device Catalogue Number: 1588H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/04/2019
• Patient Sequence Number: 1