MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 24"(60CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EP8726H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 12/02/2020, to date it has been reported that the device will not be 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 an unknown cardiovascular procedure on an unknown date and suture was used.The suture broke during use.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: 01/14/2020.A manufacturing record evaluation was performed for the finished device ppbejs, and no non-conformances were identified.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: PROLENE SUTURE 24"(60CM) 6-0 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: 10938190
• Report Number: 2210968-2020-09531
• Device Sequence Number: 11571744
• Product Code: GAW
• UDI-Device Identifier: 10705031208278
• UDI-Public: 10705031208278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 11/30/2024
• Device Model Number: EP8726H
• Device Catalogue Number: EP8726H
• Device Lot Number: PPBEJS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/14/2021
• Patient Sequence Number: 1