MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 9-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2809G
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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.Could you please confirm what was the exact issue? did you have issues (breakage) with the suture or the needle? what was the initial procedure? what is the event day and procedure date?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the device broke.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/10/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.  additional information was requested and the following was obtained: 1.Could you please confirm what was the exact issue? needle and suture are easily separated when using.2.Did you have issues (breakage) with the suture or the needle? product was discarded.3.What was the initial procedure? ps microsuturing.4.What is the event day and procedure date? (b)(6) medical personnel informed.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, 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.Product complaint # (b)(4).Date sent to the fda: 1/10/2021 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, 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: ETHILON SUTURE 5"(13CM) 9-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10968157
• Report Number: 2210968-2020-09699
• Device Sequence Number: 2322507
• Product Code: GAR
• UDI-Device Identifier: 10705031003958
• UDI-Public: 10705031003958
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/17/2020

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: 04/30/2025
• Device Model Number: 2809G
• Device Catalogue Number: 2809G
• Device Lot Number: QEBBTZ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/10/2021
• Patient Sequence Number: 1