MAUDE Adverse Event Report: ARTHREX, INC. CHONDRAL PICK, 60 DEG; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	CHONDRAL PICK, 60 DEG
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2021
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.
Event or Problem Description
It was reported that during use in an ankle arthroscopy, the ar-8656-02 pick bent and flakes went into the patient.The flakes were removed with shaver suction.
Additional Manufacturer Narrative
Complaint confirmed, the shaft is bent and the material appears to be chipped near the distal end.Material met specifications.The cause is the event is undetermined, however a likely cause of the bending is user-applied mechanical forces.The cause of the chipping is undermined, however it may be related to the bent condition.

• Brand Name: CHONDRAL PICK, 60 DEG
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11648345
• Report Number: 1220246-2021-02883
• Device Sequence Number: 17101942
• Product Code: MDM
• UDI-Device Identifier: 00888867307452
• UDI-Public: 00888867307452
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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, 60 DEG
• Device Catalogue Number: AR-8656-02
• Device Lot Number: 1392048
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1