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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic surgery after the device was implanted into the cartilage it fell out.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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.Based on the information provided which may include the device (if available and returned), pictures, videos, 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 use error.The osteochondral flap repair system using the chondral dart¿ implant surgical technique guide, lt1-000237-en-us_a, outlines the following in step 6: once inserted into the sheath, a single-shot dart inserter is used to deliver the dart into the pilot hole, recessing the dart 2 mm below the hyaline cartilage surface.Lightly tap the inserter until it contacts the back of the sheath, providing confirmation that the dart is seated.

• 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: 21773329
• Report Number: 1220246-2025-01218
• Device Sequence Number: 15472122
• Product Code: MAI
• UDI-Device Identifier: 00888867031166
• UDI-Public: (01)00888867031166(11)240401(17)270328(10)7014329
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 10/29/2025

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 Model Number: ARTHREX CHONDRAL DART, 18MM (5-BOX)
• Device Catalogue Number: AR-4005B-18
• Device Lot Number: 7014329
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown