MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	F2435H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the suture box from the product code f2435h, there are pouches of product code f2429 inside the box.There was no patient consequence reported.
Additional Manufacturer Narrative
Product complaint number: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: a photo was received for evaluation.Visual analysis of the image received from ethicon inc was observed for evaluation, a pack of paper product code f2429, in an open box with product code f2435h, lot number.Rebdqz, expiration date apr 30, 2026.We do not have the batch number of the code on the package.Image is not clear to determine failure mode or reported condition.During the packaging process, each box and each barcode on the label is scanned into the system to compare the information.As part of our quality process, manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.Complaint information will be further tracked for potential safety signals through complaint trends as part of post-market surveillance.Additional information was requested, and the following was obtained: the customer cannot provide the lot number of the pouches from the product code f2429, as the box was shipped for analysis.It seemed there were 35 pouches left in the returned box.The issue was discovered during the procedure but the patient was not be sutured yet.So, no patient consequence.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 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) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12953560
• Report Number: 2210968-2021-12375
• Device Sequence Number: 11959578
• Product Code: GAR
• UDI-Device Identifier: 10705031239036
• UDI-Public: 10705031239036
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: 04/30/2026
• Device Model Number: F2435H
• Device Catalogue Number: F2435H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• 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