MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	1669H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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's related to the reported complaint condition were identified.Summary: twenty-two unopened samples of product were returned for analysis.The complaint sample was not received.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.Per the condition of the samples received, no performance pull off - suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that the patient underwent a spine procedure in 2020 and the suture was used.When trying to use suture, the needle kept popping off the suture, like for a control release suture.Another like suture was used to complete the procedure successfully with no patient consequences.

• Brand Name: ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9789859
• Report Number: 2210968-2020-01748
• Device Sequence Number: 14096915
• Product Code: GAR
• UDI-Device Identifier: 10705031001879
• UDI-Public: 10705031001879
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 06/30/2024
• Device Model Number: 1669H
• Device Catalogue Number: 1669H
• Device Lot Number: PHE475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/04/2020
• Patient Sequence Number: 1