MAUDE Adverse Event Report: ARTHREX, INC. BUR,RND,SJ,8 FLUT 3.0MMX 7CM; BURR,SURGICAL

Model Number	BUR,RND,SJ,8 FLUT 3.0MMX 7CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
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
On 12/19/2023, it was reported by an arthrex subsidiary employee via sems (b)(4) that an ar-7300rbe burr blade broke.This was discovered during a procedure on (b)(6) 2023.Additional information requested.
Event or Problem Description
Additional information received on 1/15/2024.This was discovered during a wrist arthroscopy procedure.All broken fragments were removed.The case was completed by opening a new ar-7300rbe burr.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: b5, g4, h3, h6.The complaint is confirmed based on the customer provided photo, which shows that the burr tip was broken and abrasion marks on the shaft were noted.The most likely cause for the reported failure can be attributed to prying/leveraging the device during insertion.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual inspection, it was noted that the outer and inner tubes of the burr, round, sj, 8 flute, 3.0 mm x 7 cm were bent and broken.The tip of the inner tube was broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to allowing the rotating portion to touch any metallic object during use, that 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.

• Brand Name: BUR,RND,SJ,8 FLUT 3.0MMX 7CM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18519432
• Report Number: 1220246-2024-00357
• Device Sequence Number: 20520900
• Product Code: GFF
• UDI-Device Identifier: 00888867041967
• UDI-Public: 00888867041967
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 10/15/2024

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: BUR,RND,SJ,8 FLUT 3.0MMX 7CM
• Device Catalogue Number: AR-7300RBE
• Device Lot Number: 15034130
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 10/07/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 06/21/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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