MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 96IN 0 S/A TP-1 LP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	L880G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an unspecified plastic surgery procedure the suture was broke as it was being pulled tight through tissue.Procedure was completed with another suture from a different lot.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Representative samples were returned for evaluation.They were visually and functionally examined for tensile strength and they met the requirements.Per the condition of the representative samples, no performance - breakage suture was found on the suture and the tested sample met the finished goods requirements.In addition, a review of the batch manufacturing records for the possible batch number was conducted and the batches met all finished goods release criteria.

• Brand Name: ETHLN BLK 96IN 0 S/A TP-1 LP
• 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: 7402546
• Report Number: 2210968-2018-71963
• Device Sequence Number: 10958777
• Product Code: GAR
• UDI-Device Identifier: 10705031044906
• UDI-Public: 10705031044906
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/14/2018

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: L880G
• Device Lot Number: LMH659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1