MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 8-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8743
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being 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.H6 component code: g07002 ¿ device not returned.Related events captured via: 2210968-2024-01987.
Event or Problem Description
It was reported that patient underwent a coronary artery bypass grafting (cabg) on (b)(6) 2024, and suture was used.During the surgery, the suture was detached from the needle during continuous suture.It was not a control release needle.This happened in two products.The products were used for vascular anastomosis.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.Further details are not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/29/2024.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample determined that it was received, two detached needles that pertained to product code epm8743.This product code is double-armed.During visual inspection of the returned sample, it was observed that the needles were noted to be broken at the swage area.These samples will be shipped to hsa for further analysis due to the needle breakage.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 due to the sample needs additional evaluation by hsa.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is 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.
Additional Manufacturer Narrative
Product complaint (b)(4).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: d9, h3 investigation summary product received for analysis.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of samples a and b.The needles were received whole, as none of the cracked pieces had disconnected from the needles.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needles.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of the samples revealed the fractures were oriented in an axial direction along the region of the suture attachment, and followed features induced by the manufacturing (forming) process.Due to limitations caused by the configuration of the fracture surfaces additional conclusions could not be determined via sem.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: PRLNE BLU 2X24IN 8-0 D/A BV175-6 EP
• 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 PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18796845
• Report Number: 2210968-2024-01988
• Device Sequence Number: 15236585
• Product Code: GAW
• UDI-Device Identifier: 10705031206748
• UDI-Public: 10705031206748
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2024

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 Catalogue Number: EPM8743
• Device Lot Number: TEBJLQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 04/23/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/29/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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