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	Foreign Body In Patient (2687)
Date of Event	01/17/2023
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 surgery the instrument was inserted into the bone and the tip broke off.First the broken-off piece remained in the bone, but at the end of the surgery the surgeon could remove the tip from the ankle.There was no harm for patient, operator or third party.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.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16303155
• Report Number: 1220246-2023-06230
• Device Sequence Number: 15154285
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: 00888867044296
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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: 1391915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/06/2023
• Date Device Manufactured: 04/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown