MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation confirms the burr has broken off.The broken piece is approx.72 in long from the distal tip.The retrieved broken tip was noted to have markings along its od.Critical dimensions were measured and device met drawing specifications.The cause of this event is undetermined; however, the most likely cause is prying and/or leveraging the device during used.
Event or Problem Description
On 12/01/2021, it was reported by a sales representative via sems that an ar-300-b201 burr broke during use on calcaneus.This was discovered during use with no impact or injury to the patient, the procedure was completed successfully.

• Brand Name: BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM
• 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: 13620099
• Report Number: 1220246-2022-04510
• Device Sequence Number: 11293170
• Product Code: LXH
• UDI-Device Identifier: 00888867028654
• UDI-Public: 00888867028654
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/28/2022

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 Expiration Date: 07/31/2026
• Device Model Number: BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM
• Device Catalogue Number: AR-300-B201
• Device Lot Number: 031396
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown