MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 4-0 S/A C-3; SUTURE, NONABSORBABLE, SILK

Model Number	736G
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.Is this a product mix issue (customer receives product that is not within the same product family? it seems that this issue has occurred many times before? could you please clarify below: were these cases previously reported to ethicon? if yes, please provide a complaint reference number.If no, please create additional complaint files and provide the reference number.What is the lot number?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported by the dental rep in (b)(6) called with a question about product code: 736g permahand black silk 4-0 18 inch, c-3 needle? is this type of suture discontinued? customer states that every time she orders a box of this suture for her customer it says it comes on a c-3 needle.However, every time she receives it, it says the same code 736g, but on p-3 needle.Customer is thinking this is a manufactures error on the box.There were no adverse consequences reported.Unknown if any product is available for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SILK BLK 18IN 4-0 S/A C-3
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16369315
• Report Number: 2210968-2023-01035
• Device Sequence Number: 7843645
• Product Code: GAP
• UDI-Device Identifier: 10705031009387
• UDI-Public: 10705031009387
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

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 Model Number: 736G
• Device Catalogue Number: 736G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown