MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 5IN 9-0 S/A V100-3; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2894G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot number and no non-conformance were identified.Additional evaluation summary: representative samples were returned for evaluation.During the visual inspection samples, no defects were found on the packages.The samples were opened and the swage and attachment area were noted to be as expected; also, the tip and body of the needles were examined under magnification and no defects, damage or thinner needles were found.The sutures were dispensed without problems and examined along of the strand and no suture breakage was noted.A functional test was performed and the tensile strength force was above the minimum requirement.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.It was reported that the suture keeps breaking.Another suture was used to complete the case.No patient consequences were reported.

• Brand Name: ETHLN BLK 5IN 9-0 S/A V100-3
• 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: 8547717
• Report Number: 2210968-2019-80697
• Device Sequence Number: 1730597
• Product Code: GAR
• UDI-Device Identifier: 10705031004276
• UDI-Public: 10705031004276
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2019

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: No Information
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 2894G
• Device Lot Number: MMZ131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2019
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1