MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 2 X 24"(60CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8747
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: suture breakage occurred with devices in 2 packages during vascular anastomosis by continuous suturing.The positions of breakage were almost same in all the affected sutures.The affected sutures were used by tying them at the breakage point, thus, they will not be returned.Some unopened packages will be returned.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 a coronary artery bypass graft procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture broke during vascular anastomosis by continuous suturing.The operation time was extended within 30 minutes.The affected suture was used by tying them at the breakage point.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/13/2020.Additional information: d10, h4, h6.A manufacturing record evaluation was performed for the finished device batch pmr719 and no non-conformances were identified.Additional h3 investigation summary: an opened box with eleven unopened samples of product code epm8747, lot # pmr719 were returned for analysis.The complaint sample was not received for evaluation.The product code is multistrands and the packet contains two strands double armed per packet.During the visual inspection of eleven unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area of all needles 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 samples received, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: PROLENE SUTURE 2 X 24"(60CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9978401
• Report Number: 2210968-2020-03220
• Device Sequence Number: 16987907
• Product Code: GAW
• UDI-Device Identifier: 10705031203693
• UDI-Public: 10705031203693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 03/26/2020

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: 10/31/2024
• Device Model Number: EPM8747
• Device Catalogue Number: EPM8747
• Device Lot Number: PMR719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/13/2020
• Patient Sequence Number: 1