MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 30IN 3-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8528H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).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.Additional information was requested, and the following was obtained: what do you mean by "the sutures which break at a low tension threshold" do you mean the sutures broke during the procedure? yes, the sutures broke without exerting excessive tension.Did 6 wires break during this single patient's procedure? yes: (b)(4) 2020 during the installation of a heartware.The following information was requested, but unavailable: what tissue was being approximated or sutured when it broke? events submitted via (b)(4).
Event or Problem Description
It was reported that the patient underwent a cardiac surgery on (b)(6) 2020 and the suture was used.During installation of heart ware, a fragility of suture which break at a low tension threshold was noted.The suture broke without exerting excessive tension.Another like suture box from the same batch was opened to finish the procedure without problem.There were no clinical consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/18/2020.A manufacturing record evaluation was performed for the finished device lot number qbbehd/8528h56, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: an empty overwrap packet, a labeled winding former with two needles/sutures piece of product code 8528, lot # qbbehd were received for evaluation.During the visual inspection of the sample, the ends of the suture was observed broken due to stress applied, no body fluids or marks by surgical instrument could be observed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.No conclusion could be reached as on what caused a fragility on the sutures which break at a low tension threshold.Additional h3 investigation summary: an unopened sample of product code 8528, lot # qbbehd were received for evaluation.During the visual inspection of the unopened 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 noted.A functional test was performed 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.The device performed without any defect noted.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, or its employees that the report constitutes an admission that the product, ethicon, 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: PROLENE BLU 30IN 3-0 D/A SH
• 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: 10717237
• Report Number: 2210968-2020-08192
• Device Sequence Number: 14218202
• Product Code: GAW
• UDI-Device Identifier: 10705031091108
• UDI-Public: 10705031091108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/29/2020

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: 01/31/2025
• Device Model Number: 8528H
• Device Catalogue Number: 8528H
• Device Lot Number: QBBEHD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1