MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A FS-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	663H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: thirty-two unopened samples of product code 663, lot mhb832 were received for analysis.The complaint sample was not returned for analysis.During the visual inspection of thirteen unopened samples, no defects were observed on the packets.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were examined along of strand and no defects or damaged were noted.A functional test was performed on the samples and the tensile force met the requirements.Per the condition of the representative samples, no performance breakage suture was observed, and the tested sample meet the finished goods requirements.A manufacturing record evaluation was performed for the finished device lot number mhb832- 663h55, and no non-conformance's were identified.
Event or Problem Description
It was reported that the patient underwent a bariatric procedure on unknown date in (b)(6) 2019 and suture was used.The suture broke when used on the skin.Another like device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: ETHLN BLK 18IN 3-0 S/A FS-1
• 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: 8537650
• Report Number: 2210968-2019-80583
• Device Sequence Number: 16751962
• Product Code: GAR
• UDI-Device Identifier: 10705031007789
• UDI-Public: 10705031007789
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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
• Report Date (Section B): 03/26/2019

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 663H
• Device Lot Number: MHB832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1