MAUDE Adverse Event Report: ETHICON INC. MERSILENE SUTURE 36"(90CM) 5MM WHT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9212
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a total hip procedure on (b)(6) 2018 and a suture was used.During surgery, the suture was popping off the needle at the swage.The procedure was completed with a replacement device.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/30/2018.The actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: batch mdh105 mfg date: 04/04/2018, exp date: 03/31/2023.Batch lpj446 mfg date: 12/27/2017, exp date: 11/30/2022.The device history records for the possible batch numbers were reviewed and the manufacturing criteria were met prior to the release of this lot.Evaluation: four unopened samples of product were returned for analysis.The issue sample was not received for evaluation.During the visual inspection of four unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand with no defects or damages observed.A functional test was performed and the pull force was above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no suture needle pull off was found, and the tested samples met the finished goods requirements.

• Brand Name: MERSILENE SUTURE 36"(90CM) 5MM WHT
• 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: 8037550
• Report Number: 2210968-2018-76911
• Device Sequence Number: 11059760
• Product Code: GAT
• UDI-Device Identifier: 10705031032422
• UDI-Public: 10705031032422
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2018

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 Catalogue Number: D9212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/07/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/01/2018
• Patient Sequence Number: 1