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

Model Number	M8704
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cabg surgery on (b)(6) 2021 and suture was used.During the procedure, the needle detached from the needle.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When did the needle detach (in the package, during removal from package, during handling or during use on the patient)? please specify for each of the 4 involved devices.Events reported in 2210968-2021-09813, 2210968-2021-09814, 2210968-2021-09815.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/29/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational narrative: thirty six packets of product code m8704 were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and the swage and attachment area were noted with incorrect swage (bellmouth) and due to condition observed, the rest of the samples were examined and incorrect swage was found.Functional test was performed to thirteen samples, and the pull force result were above the minimum requirements.The incorrect swage defect been correlated to the manufacturing process.Based on the information currently available, incorrect swage was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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 CC MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12650605
• Report Number: 2210968-2021-09817
• Device Sequence Number: 16453791
• Product Code: GAW
• UDI-Device Identifier: 10705031045798
• UDI-Public: 10705031045798
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 03/31/2026
• Device Model Number: M8704
• Device Catalogue Number: M8704
• Device Lot Number: RDBBRT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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