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

Model Number	CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an ankle procedure, when the surgeon placed the chondral pick inside the ankle joint, over the lesion and applied pressure the tip of the pick snapped off.The fragment was retrieved out of the joint of the patient and the case was completed by using a new ar-8655-06.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the ar-8655-06 device with breakage at the distal tip.However, as the device was not returned for investigation, the cause remains undetermined.No change in harm was identified.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8655-06, batch 4751305 chondral pick was received for investigation.Visual inspection identified that the distal tip of the pick had broken off.The fragment was not returned for analysis.It was observed that the shaft of the pick was significantly bent, indicating that the device had been subjected to prying/leveraging forces.As such, this event is consistent with user-applied mechanical forces to the device during use.

• Brand Name: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12362350
• Report Number: 1220246-2021-03554
• Device Sequence Number: 14336753
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: 00888867044296
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 10/20/2021

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, ANKLE ARTHROSCOPY, 60 DEG
• Device Catalogue Number: AR-8655-06
• Device Lot Number: 4751305
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 08/03/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/08/2021; 10/20/2021
• Patient Sequence Number: 1