MAUDE Adverse Event Report: ARTHREX, INC. DISP KIT FOR DX SWIVELOCK SL, 3.5X8.5MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	DISP KIT FOR DX SWIVELOCK SL, 3.5X8.5MM
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
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 device was not received for evaluation.Based on the information provided, the most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
It was reported the implant kit was not sealed on one side and when they were brought to the field the components fell out of the packaging onto the ground.It was replaced and the case was completed with no further issues.

• Brand Name: DISP KIT FOR DX SWIVELOCK SL, 3.5X8.5MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 19481656
• Report Number: 1220246-2024-04925
• Device Sequence Number: 12846080
• Product Code: MBI
• UDI-Device Identifier: 00888867204355
• UDI-Public: 00888867204355
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• 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): 06/05/2024

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 Expiration Date: 09/30/2025
• Device Model Number: DISP KIT FOR DX SWIVELOCK SL, 3.5X8.5MM
• Device Catalogue Number: AR-8978DS-01
• Device Lot Number: 11975008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• 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