MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 2 X 18"(45CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8736
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Summary: three empty opened straight pack and an unopened sample received for evaluation.The product code is multi-strand and contains two strands per packet.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were found.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative sample, no performance - breakage suture was found and the tested sample met the finished goods requirements.Representative samples returned to support investigation of unknown quantity of device issues captured in reports 2210968-2019-86071 and 2210968-2019-86072.Analysis results have been included in initial reports for each.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2019 and the suture was used.It was reported that the suture kept breaking during the anastomosis.It was not reported how the procedure was completed.There were no patient consequences reported.
Additional Manufacturer Narrative
It was reported that a patient underwent a coronary artery bypass grafting/cabg times 2 on (b)(6) 2019 and the suture was used.While physician was suturing an anastomosis of the heart, the suture broke half way around.There were no patient consequences reported.This medwatch report is in response to receipt of voluntary medwatch event report (b)(4).

• Brand Name: PROLENE SUTURE 2 X 18"(45CM) 7-0 BLU
• 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: 8926383
• Report Number: 2210968-2019-86072
• Device Sequence Number: 242727
• Product Code: GAW
• UDI-Device Identifier: 10705031203679
• UDI-Public: 10705031203679
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 04/30/2023
• Device Catalogue Number: EPM8736
• Device Lot Number: MEH216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 08/23/2019
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 106