MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 60CM M0.5 USP7/0 DBLE ARMED BV175-7 EVERPOINT; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8768
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.Additional information was requested, and the following was obtained via: was there any adverse consequence associated with the patient? no device return status.Please document the shipment tracking number: available, not shipped, awaiting shipper kit.What is the total number of products involved in this event?: 1.What is the total number of needles that popped off at the swage?: 2.What is the total number of bent needles involved in this event?: 1.Based on side note: there were a few other incidents with a diff evp code (jjhcs acct 73838) diff hospital where similar complaints were reported a few months ago.Odd to be hearing from diff surgeons at diff accounts.New pack was opened to complete procedure.What is the total number of procedures?: 3.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Will lookup and reply separately if this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).This has been for the cases we have been made aware of.H3 device analysis: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned sample determined that it was received one open straight packet with an unused strand double-armed that pertain to the product code epm8768.This product code required two strands double armed per packet.Upon visual inspection of the returned sample, it was noted one strand double armed.The swage and attachment area of needles were noted to be as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during the evaluation.In addition, the needles were examined and no issues related to bending needles could be observed.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2023-03643.
Event or Problem Description
It was reported that a patient underwent a cabg procedure (b)(6)2023 and suture was used.During the procedure, it was reported by the sales rep that during the cabg procedure the doctor and cv team stated that these evp needles are popping off at the swage.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE BLU 60CM M0.5 USP7/0 DBLE ARMED BV175-7 EVERPOINT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16950389
• Report Number: 2210968-2023-03641
• Device Sequence Number: 11629576
• Product Code: GAW
• UDI-Device Identifier: 10705031211681
• UDI-Public: 10705031211681
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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: EPM8768
• Device Catalogue Number: EPM8768
• Device Lot Number: SLBHRP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown