MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX CHONDRAL DART, 18MM (5-BOX); BIO SOFT TISSUE FIXATN FASTNR

Model Number	ARTHREX CHONDRAL DART, 18MM (5-BOX)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/10/2025, it was reported by an arthrex subsidiary employee via email that an ar-4005b-18 chondral dart ruptured inside the patient.The case was completed with the placement of additional implants.No further details were provided.This occurred during an osteochondral flap fixation procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted what appeared to be broken fragments of an ar-4005b-18 chondral dart.Based on the information provided which may include pictures, the event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: ARTHREX CHONDRAL DART, 18MM (5-BOX)
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 21992824
• Report Number: 1220246-2025-01959
• Device Sequence Number: 8553327
• Product Code: MAI
• UDI-Device Identifier: 00888867031166
• UDI-Public: (01)00888867031166(11)230901(17)260828(10)7013150
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K082999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: 08/28/2026
• Device Model Number: ARTHREX CHONDRAL DART, 18MM (5-BOX)
• Device Catalogue Number: AR-4005B-18
• Device Lot Number: 7013150
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown