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	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/30/2024, it was reported by a distributor via (b)(4) that an ar-8655-06 chondral pick, ankle arthroscopy, 60 degree had the tip break inside the patient (see photo attachment).The case was delayed 15 minutes for the surgeon to retrieve the broken piece in the ankle.This was discovered during a procedure, with no reported patient harm.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.Photographic evidence provided from the field of an unpackaged ar-8655-06, with batch number 1392125, revealed a damaged distal tip.Therefore, arthrex was able to deduce the cause of the complaint as misuse.The most likely cause can be attributed to misaligned insertion or prying/leveraging the device during use.

• 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: 20547090
• Report Number: 1220246-2024-08279
• Device Sequence Number: 7817123
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: (01)00888867044296(11)210624(10)1392125
• 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): 08/18/2025

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: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Device Catalogue Number: AR-8655-06
• Device Lot Number: 1392125
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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