MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 10 FLUTE, 3.0MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	BURR, ROUND, 10 FLUTE, 3.0MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2024
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.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
On 02/27/2024, it was reported by an arthrex subsidiary employee via email that the tip of an ar-9300rbt burr broke off during use.This was discovered during a procedure on (b)(6) 2024.All broken fragments were removed.Additional information requested.Additional information provided 3/4/24: the procedure performed was a cm joint repair.An ar-9300rbt was used to complete the case.No case delay, no additional anesthesia administered.
Additional Manufacturer Narrative
Additional information: d9, g3, h6 the complaint allegation was confirmed.One unpackaged ar-9300rbt batch 15047596 was received for evaluation.A functional test was not performed because the device was received damaged.Evaluation of the returned device noted that the tip was broken off at the weld.The observed condition is likely due to prying/levering the device against hard bone or other instrumentation during use.According to dfu-0215-7, at revision 0.F.Precautions.6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.Damage to the device can range from a slight distortion or dulling of the blade/burr edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.7.Excessive ¿side-loading¿ on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.

• Brand Name: BURR, ROUND, 10 FLUTE, 3.0MM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 18867865
• Report Number: 1220246-2024-01369
• Device Sequence Number: 11515296
• Product Code: GFF
• UDI-Device Identifier: 00888867215696
• UDI-Public: 00888867215696
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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, ROUND, 10 FLUTE, 3.0MM
• Device Catalogue Number: AR-9300RBT
• Device Lot Number: 15047596
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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