MAUDE Adverse Event Report: ETHICON INC. PRONOVA* BLUE MONO; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	D10114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 an unknown cardiovascular surgery on (b)(6) 2019 and suture was used.During the procedure, the suture was frayed and broke.The surgeon commented that he felt unusual feeling in using obviously though it was used as usual.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/17/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional h3: it was reported that the device had a breakage suture issue.Seventy-one unopened samples were returned for analysis.The complaint sample was not received.During the visual inspection of thirteen 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 of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2019-82848, 2210968-2019-82849, and 2210968-2019-82850.Analysis results have been included in follow-up reports for each.

• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8707497
• Report Number: 2210968-2019-82848
• Device Sequence Number: 16599760
• Product Code: GAW
• UDI-Device Identifier: 10705031203396
• UDI-Public: 10705031203396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: D10114
• Device Lot Number: MCJ610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1