MAUDE Adverse Event Report: ARTHREX, INC. CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/02/2025, it was reported by a sales representative via (b)(4) that an ar-8655-06 chondral pick tip broke into ankle articulation.Surgery was delayed retrieving the broken tip.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8655-06 batch 1392005 was received for evaluation.Visual inspection revealed that the instrument's tip was broken off; the fragment recovered during the event was not returned for investigation.A bend was observed at the distal end of the shaft close to the tip.A functional test cannot be performed due to the device's damage.The most likely cause of the reported failure is user error, specifically the application of excessive force to a device that may have been weakened by wear and tear from repetitive reprocessing (manufacturing date: 2020).Directions for use dfu-0023-eo, revision 5, section c.Validation repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to repeated use and/or reprocessing.The user assumes liability and is responsible for the use of a damaged or dirty device.

• Brand Name: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 23878448
• Report Number: 1220246-2025-05772
• Device Sequence Number: 20010291
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: (01)00888867044296(11)200204(10)1392005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Device Catalogue Number: AR-8655-06
• Device Lot Number: 1392005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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