MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	F2413H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc (b)(4).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 was obtained: did the two pull off's occurred during use on the patient? or did they occurred upon handling/dispensing before use on the patient? yes after 2 passings.Procedure name? open carpal tunnel note" events reported in 2210968-2021-04922.
Event or Problem Description
It was reported that a patient underwent an open procedure for carpal tunnel on (b)(6)2021 and suture was used.During the procedure, the needle pulled off from the wire.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/26/2021.H6 component code: g07002 - device not returned.Additional information: h6, h4, d4.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.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: ETHILON SUTURE 30IN(75CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11872093
• Report Number: 2210968-2021-04923
• Device Sequence Number: 3215758
• Product Code: GAR
• UDI-Device Identifier: 10705031238916
• UDI-Public: 10705031238916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/29/2021

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: 12/31/2025
• Device Model Number: F2413H
• Device Catalogue Number: F2413H
• Device Lot Number: RABCLT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/26/2021
• Patient Sequence Number: 1