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

Model Number	AR-8655-05
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
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 a chondropick wrist surgery the tip of the device broke off inside the patient.The surgeon was able to retrieve the part out of the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different chondropick.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8655-05, batch 1391925 30° chondral pick was received for investigation.Visual inspection identified that the 30° tip at the distal end of the shaft had broken off.The fragments generated during this event were not returned for analysis.It was also identified that the outer diameter of the distal tip was cracked approximately 0.6988mm from the breakage point.The observed condition is consistent with user applied mechanical forces via prying/leveraging the device during use.

• 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: 11472764
• Report Number: 1220246-2021-02700
• Device Sequence Number: 14194512
• Product Code: MDM
• UDI-Device Identifier: 00888867044289
• UDI-Public: 00888867044289
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: AR-8655-05
• Device Catalogue Number: AR-8655-05
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/26/2021
• Patient Sequence Number: 1