MAUDE Adverse Event Report: ARTHREX, INC. CHONDRO PICK 60 DEGREE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CHONDRO PICK 60 DEGREE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex subsidiary employee via sems-06042306 that an ar-1763 chondro pick tip broke off.This occurred during a knee arthroscopy procedure on (b)(6) 2023 while making the micro-drills in patient's knee.The fragment was retrieved and the case was completed.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which shows that the distal end of the shaft was broken.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Device manufactured date 2016.
Event or Problem Description
Additional information was provided on (b)(6) 2024 where the arthrex subsidiary employee stated that the patient had good bone quality and that the incident occurred at the end of the bone punctures, and the surgeon was satisfied with what had already been punctured.

• Brand Name: CHONDRO PICK 60 DEGREE
• 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: 18001830
• Report Number: 1220246-2023-08349
• Device Sequence Number: 15354416
• Product Code: LXH
• UDI-Device Identifier: 00888867021129
• UDI-Public: 00888867021129
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/26/2024

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: CHONDRO PICK 60 DEGREE
• Device Catalogue Number: AR-1763
• Device Lot Number: 011616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2016
• 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