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	02/22/2021
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 an ankle arthroscopy case as the surgeon went to go microfracture a lesion; the ar-8655-06 pick tip just broke off.It then took the surgeon about 30-45 minutes to fish it out.The rep reported there were no unplanned incisions needed in order to remove the broken piece.The case was completed as planned after the broken tip was removed arthroscopically.
Additional Manufacturer Narrative
It was reported that the tip broke off.The reported event is confirmed upon investigation of the returned pictures.Visual evaluation identified that the distal end of the device had fractured off.Patient bone quality and surgical technique were not provided in the complaint.Additionally, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• 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: 11545611
• Report Number: 1220246-2021-02765
• Device Sequence Number: 3402725
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: 00888867044296
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1