MAUDE Adverse Event Report: ARTHREX, INC. FOREFOOT FUSION MODULE INSTRUMENT CASE; TRAY, SURGICAL INSTRUMENT

Model Number	FOREFOOT FUSION MODULE INSTRUMENT CASE
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 08/18/2022 by a sales representative via email that an ar-8944c instrument tray is bleeding ink.This was discovered during an unspecified time with no patient harm.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.(1) unpackaged ar-8944c was received for evaluation.Visual inspection noted signs of wear around the cases, including scratches.An alcohol wipe on the blue area of the lid revealed pigment was coming off on the wipe.Capa-00373 was initiated to investigate the root cause of this issue.A probable cause could be attributed to the anodic coat sealing eroding after a cycle of washing and sterilizing.Another potential cause could be a design issue, where the high density of pigment required for full-color corner background can lead to more pigment being deposited than the anodized aluminum pores can hold, resulting in bleeding of pigmentation.The most likely cause for the reported failure is attributed to a supplier process issue.

• Brand Name: FOREFOOT FUSION MODULE INSTRUMENT CASE
• Common Device Name: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19384776
• Report Number: 1220246-2024-03762
• Device Sequence Number: 12491081
• Product Code: MDM
• UDI-Device Identifier: 00888867052857
• UDI-Public: 00888867052857
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: FOREFOOT FUSION MODULE INSTRUMENT CASE
• Device Catalogue Number: AR-8944C
• Device Lot Number: 10752134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown