MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 36IN 5-0 D/A RB-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	3556H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot paj147, and no non-conformance's were identified.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 aortic valve replacement surgery on (b)(6) 2019 and suture was used.During the procedure, the suture broke during continuous suturing.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 02/05/2020.Additional information: d10.Investigation summary: it was reported performance breakage suture.Unopened samples of product code 3556, lot # paj147 were returned for analysis.During the visual inspection of thirteen 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 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.

• Brand Name: PRNVA BLU 36IN 5-0 D/A RB-1
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9554295
• Report Number: 2210968-2020-00120
• Device Sequence Number: 3403362
• Product Code: GAW
• UDI-Device Identifier: 10705031004498
• UDI-Public: 10705031004498
• 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): 12/11/2019

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: 12/31/2023
• Device Model Number: 3556H
• Device Catalogue Number: 3556H
• Device Lot Number: PAJ147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1