MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURES - NON-ABSORBABLE

Model Number	EP8776H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 10/19/2022.Component code: g07002 - incomplete device returned.Incomplete device returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received one open overwrap packet with one empty labeled winding former and one detached needle that pertain to product code ep8776.The visual assessment of the needle noted that the swage and attachment area was observed as expected.The barrel hole of the needle was examined under 20x magnification, and no suture remnant was found.In addition, the suture was not returned for evaluation to determine the assignable cause.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 to what caused the reported complaint.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.
Event or Problem Description
It was reported that a patient underwent a av fistura procedure on (b)(6) 2022 and suture was used.During the procedure, the needle popped off of swaged everpoint prolene when surgeon was pulling suture through vessel.A new 6-0 everpoint prolene was obtained.The procedure was competed with no patient consequences.Additional information was requested.

• Brand Name: PROLENE SUTURE 30"(75CM) 6-0 BLU
• Common Device Name: SUTURES - NON-ABSORBABLE
• 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 ; 9083863534
• MDR Report Key: 15630817
• Report Number: 2210968-2022-08554
• Device Sequence Number: 5873440
• Product Code: GAW
• UDI-Device Identifier: 10705031231238
• UDI-Public: 10705031231238
• 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): 10/19/2022

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: EP8776H
• Device Catalogue Number: EP8776H
• Device Lot Number: SGBCAK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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: Male