MAUDE Adverse Event Report: ARTHREX, INC. CHONDRAL PICK, ANKLE ARTHROSCOPY, 30 DEG; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	CHONDRAL PICK, ANKLE ARTHROSCOPY, 30 DEG
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2020
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 a surgery chisel cap shattered when it was hit with the hammer.It was further reported that the fragments were scattered inside the patient and that it could be that this caused some kind of contamination.No further information were provided.Update 04-nov-2020: further information were provided that the reported event occurred during a foot and ankle surgery with micro fracturing.The surgeon further reported that the fragments were removed and the wound irrigated accurately.However the fragments were very small and removal of all of them could not be guaranteed.
Additional Manufacturer Narrative
Complaint confirmed, the impactor cap was found to be broken.The loose fragment was also cracked and discolored.The handle of the device was found to be dented and discolored.Likely cause of the damage observed are user-applied mechanical forces; improper cleaning.

• Brand Name: CHONDRAL PICK, ANKLE ARTHROSCOPY, 30 DEG
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10860971
• Report Number: 1220246-2020-02345
• Device Sequence Number: 2602100
• Product Code: MDM
• UDI-Device Identifier: 00888867044289
• UDI-Public: 00888867044289
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: CHONDRAL PICK, ANKLE ARTHROSCOPY, 30 DEG
• Device Catalogue Number: AR-8655-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other