MAUDE Adverse Event Report: ETHICON INC. NONABS SUR SUT USP ETHILON NW3336P; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number NW3336P

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an orthopedic procedure on (b)(6) 2023 and suture was used.During the procedure, the suture broke.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: g07002 - device not returned.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 lot, and no non-conformances were identified.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 via: - was there any adverse consequence associated with the patient? : there were no adverse consequences reported.Events reported via: 2210968-2023-10157.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 3/8/2024 additional information was requested, the following was obtained: product code unknown multifilament, lot unknown.Could you please clarify if the additional device belongs to this complaint? if yes, did a device malfunction occur during the same procedure? if not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.If the device was not reported before, please provide more details of device malfunction.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.The additional device found may be accidently packed by the ot its not relevant to the complaint raised.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: NONABS SUR SUT USP ETHILON NW3336P
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-AURANGABAD INDIA; b-15/1, midc area; waluj; aurangabad ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18397955
• MDR Text Key: 331383372
• Report Number: 2210968-2023-10156
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NW3336P
• Device Lot Number: V2060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1