MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 8IN 10-0 D/A STC-6; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	1713G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.It was reported that the health care professional received a product where the needle description did not match description in the system.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/26/2023.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.H6 component code: g07002 device not returned.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.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.Were there any patient consequences? could you please provide the lot number? could you please confirm if an incorrect device was found on the package or if the product description in the package was incorrect.Could you please provide photos of the product for analysis? procedure name? is this device available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number).

• Brand Name: PRLNE BLU 8IN 10-0 D/A STC-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 16814532
• Report Number: 2210968-2023-02993
• Device Sequence Number: 5522761
• Product Code: GAW
• UDI-Device Identifier: 10705031002227
• UDI-Public: 10705031002227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 1713G
• Device Catalogue Number: 1713G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/26/2023
• 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