MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV175-6 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8735
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft on (b)(6) 2020 and suture was used.During the procedure, the suture was broken easily at the 1st stitch during continuous suturing on the coronary artery.Another package was used with no problem.The operation time was extended within 30 minutes.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/2/2020 additional information: d10, g1, h6 additional information: d4 ¿ the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch number: batch plh555, mfg.Date: 10/16/2019; exp.Date: 9/30/2024 a manufacturing record evaluation was performed for the finished device possible lot number plh555-m875519, and no non-conformances were identified.Additional h3 investigation summary: it was reported breakage suture.One needle-suture in two section of product code m8735 was received for analysis.During the visual inspection of the opened sample (two needle/suture pieces), the swage and attachment area were noted to be as expected.However, end of the suture pieces cut that appears to be by the use of a surgical instrument could be observed.In addition, the functional test was performed in a suture piece and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A BV175-6 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10384980
• Report Number: 2210968-2020-06005
• Device Sequence Number: 1865446
• Product Code: GAW
• UDI-Device Identifier: 10705031045996
• UDI-Public: 10705031045996
• 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): 07/31/2020

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 Model Number: M8735
• Device Catalogue Number: M8735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/02/2020
• Patient Sequence Number: 1