MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 5.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 8 FLUTE 5.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems-06717638 that an ar-8500obe burr produced debris."during the use of the bone shaver blade, several steel filaments came loose inside the joint.It was not possible to remove all the filaments from inside the joint.According to the doctor, there was no impact on the patient and the fragments will only be seen during imaging tests.The package was intact with no damage.There was no increase in surgical time." this was discovered during use in a case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided pictures noted several steel filaments came loose inside the joint.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: BURR, OVAL, 8 FLUTE 5.0MM X 13CM
• 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: 20869019
• Report Number: 1220246-2024-08756
• Device Sequence Number: 8622286
• Product Code: GFF
• UDI-Device Identifier: 00888867043862
• UDI-Public: (01)00888867043862(11)230914(17)280831(10)15141583
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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, OVAL, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500OBE
• Device Lot Number: 15141583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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