MAUDE Adverse Event Report: Ethicon Inc. PROLENE; Sutures - Non-Absorbable

Catalog Number	EP8766H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.A nurse confirmed that the suture was frayed after opening the package.This event was found before use.It was not a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.The product was returned for evaluation, and a foreign matter was identified during the investigation of the sample received.
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.H3 investigation summary.The product was returned to eth for evaluation.Visual inspection revealed one labeled winding former with a needle suture combination outside the foil packet was received for analysis.Product code ep8766.During the initial inspection of the returned sample, a dented and broken suture was observed.The needle-suture combination was dispensed from the winding former and examined; no damage or defects were identified.It was further determined that the damaged suture fragment was not part of the needle-suture combination contained within the winding former.Therefore, the fragment was identified as foreign material.Based on the information currently available, a foreign matter was identified during the investigation of the sample received.This product issue will be addressed through eth quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• Brand Name: PROLENE
• 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 00754 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50888929
• Report Number: 2210968-2026-09623
• Device Sequence Number: 16141017
• Product Code: GAW
• UDI-Device Identifier: 10705031212435
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial

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: EP8766H
• Device Lot Number: 102A63
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2024
• 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