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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
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 the device broke during an ankel microfracture surgery.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 18-feb-2021: it was confirmed that the device broke off inside the patient and the broken off piece was retrieved from the patient.The breakage didn¿t cause any harm.Update 23-feb-2021: the wrong lot was registered in the complaint form.The actually affected lot is 1391846.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the distal tip of the returned chondral pick had broken off.No fragments were returned for inspection.The cause is undetermined.However a most likely cause is user applied mechanical forces, such as through prying/leveraging, 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: 11436803
• Report Number: 1220246-2021-02687
• Device Sequence Number: 20126277
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: 00888867044296
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 09/15/2021

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
• Device Lot Number: 1391846
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1