MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 60IN 1 S/A TP-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	824G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 a mastopexy with prosthesis procedure on (b)(6) 2019 and suture was used.It was reported that the threads were bursting easily.A similar product was used to continue the procedure.No adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional evaluation summary: an empty opened overwrap, a foil with an empty folder and a dispensed needle suture of product code 824, lot mbh211 were received for analysis.During the visual inspection of the sample, no defects were observed.The swage and attachment area were noted to be as expected.The suture was 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 sample, no performance breakage suture was observed, and the tested sample met the finished goods requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: ETHLN BLK 60IN 1 S/A TP-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: 8445879
• Report Number: 2210968-2019-79628
• Device Sequence Number: 16897399
• Product Code: GAR
• UDI-Device Identifier: 10705031013667
• UDI-Public: 10705031013667
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 01/31/2023
• Device Catalogue Number: 824G
• Device Lot Number: MBH211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/06/2019
• Patient Sequence Number: 1