MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A CC-1 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8707H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 12/12/2024.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, or its employees that the report constitutes an admission that the product, ethicon, 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.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: please confirm, did one needle pull off the needle during the procedure? please clarify, it was reported that fragments generated.Did the needle fall into the patient? h3 investigational summary: the product was returned to ethicon for evaluation.One needle suture in two sections that belong to product code 8707h was received for analysis.This product code is double-armed.During visual inspection of the returned sample, the swage and attachment area were noted as expected.The suture pieces were examined, and the ends of the suture were noted broken probably due to excessive force applied.In addition, the sutures were noted elongated.A functional test was performed in a suture piece using instron equipment and the tensile force was above the minimum requirements.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as to what caused the reported complaint.As part of the 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.
Event or Problem Description
It was reported that a patient underwent a vascular procedure on (b)(6) 2024 and suture was used.During the procedure, the sutures break off both needles.The suture broke in the middle not right at the end.Dr.Says no force was applied when it happened.There were no patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 30IN 6-0 D/A CC-1 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20923716
• Report Number: 2210968-2024-13390
• Device Sequence Number: 18221179
• Product Code: GAW
• UDI-Device Identifier: 10705031019461
• UDI-Public: (01)10705031019461(17)280731(10)TJBKRZ
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: 8707H
• Device Lot Number: TJBKRZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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