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	Insufficient Information (4580)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/13/2023, it was reported by an arthrex subsidiary employee via sems-06030389 that an ar-8655-06 chondral pick broke inside the patient, causing difficulties for the doctor to remove the broken part.No additional information was provided.Additional information requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the reported event is not confirmed.The most likely cause for the reported failure can be attributed to user error due to excessive force used prying/leveraging the device during insertion.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Visual inspection identified that the distal end of the tip of the chondral pick, ankle arthroscopy, 60 degree had broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to excessive force used prying/leveraging the device during insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17912845
• Report Number: 1220246-2023-08134
• Device Sequence Number: 6653605
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: 00888867044296
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/17/2024

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 Model Number: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Device Catalogue Number: AR-8655-06
• Device Lot Number: 1392051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 05/14/2024; 10/08/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 06/10/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown