MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT 20 MM, DIA. 3.1 MM; BURR,SURGICAL

Model Number	BURR, STRAIGHT 20 MM, DIA. 3.1 MM
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/05/2024, it was reported by a sales representative via (b)(4) that an ar-300-b202 burr was causing the shaver to overheat.This occurred during use in a case with no patient effect."once the incision was made the surgeon started to use the burr on the calcaneus.Within minutes the hand piece was starting to get warm.Irrigation was flowing as normal.We then switched out the burr for a different one and the hand piece cooled off and worked as it should.".

• Brand Name: BURR, STRAIGHT 20 MM, DIA. 3.1 MM
• Common Device Name: BURR,SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 18942717
• Report Number: 1220246-2024-01567
• Device Sequence Number: 14195524
• Product Code: LXH
• UDI-Device Identifier: 00888867185821
• UDI-Public: 00888867185821
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 03/20/2024

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: BURR, STRAIGHT 20 MM, DIA. 3.1 MM
• Device Catalogue Number: AR-300-B202
• Device Lot Number: 060444
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown