MAUDE Adverse Event Report: ETHICON INC. ETHLN CLR 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	691G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in 2210968-2021-01708.Additional information was requested and the following information was obtained: was the needle removed from the patient during the same procedure? no further information is available.What tissue structure is it located? no further information is available.Event date? no further information is available.Device return status/follow up? we regularly contact with sales rep about the device returning.No further information will be provided.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.
Event or Problem Description
It was reported that a patient underwent an unknown dental and oral surgery on an unknown date and a suture was used.During the procedure, the suture was detached from the needle easily.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 04/16/2021.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, h4, h6 h3 analysis summary: the product was returned to ethicon inc for evaluation.Visual analysis of the returned sample determined that one opened sample of product code 691g was received for evaluation.Clip off defect could be observed in the sample.The visual inspection concluded that the needle detached from the suture, the barrel hole was examined under 20x magnification and remnant suture was noted, the suture end is severely cut.The functional test could not be performed.The clip off defect has been correlated to the manufacturing process.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.Based on the information currently available, the clip off was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.A manufacturing record evaluation was performed for the finished device batch pgj329, 691g55 and no non-conformances were identified.Events reported in 2210968-2021-01708 and 2210968-2021-01709 (b)(4) date sent to fda: 04/16/2021 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: ETHLN CLR 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11367726
• Report Number: 2210968-2021-01709
• Device Sequence Number: 16358256
• Product Code: GAR
• UDI-Device Identifier: 10705031008434
• UDI-Public: 10705031008434
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: No Information
• Device Expiration Date: 05/31/2024
• Device Model Number: 691G
• Device Catalogue Number: 691G
• Device Lot Number: PGJ329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1