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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events related to ethln clr 18in 4-0 s/a p-3 prm mp captured via 2210968-2021-04348.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.Additional information was requested and the following information was obtained: what was the name of the initial procedure? no further information is available.What was used to complete the procedure? no further information is available.In relation to needle, what is the approximate location of suture breakage? no further information is available.Did the suture separate completely? suture breakage occurred with two (2) products.Based on the report from the sales rep, it is supposed that both sutures broke completely.However, we've not confirmed this on the actual products.What tissue was being approximated or sutured when it broke? this issue occurred during suturing on the skin.Device return status/follow up? we regularly contact with sales rep about the device returning.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 6/16/2021.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.A manufacturing record evaluation was performed for the finished device batch plq001, and no non-conformances were identified.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one used needle/suture piece of product code 691g was received for evaluation, the swage and attachment area was noted to be as expected, the suture piece was observed with body fluids and the end was cut appears to be by use of the surgical instrument.No functional test can be performed due to sample condition.The condition of the sample received indicates improper handling of the device.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.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• 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 08869
• MDR Report Key: 11793047
• Report Number: 2210968-2021-04347
• Device Sequence Number: 3869651
• 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): 04/20/2021

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: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 691G
• Device Catalogue Number: 691G
• Device Lot Number: PLQ001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1