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

Model Number	BLURR, 5.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a sales representative reported via (b)(4) that an ar-8500bl blurr was leaving metal shavings in the shoulder during subacromial decompression.The speed was set to 8000 forwards.Metal shavings were then removed using an ar-8400dc shaver.No harm to the patient was reported, and the case was finished in the usual manner.This was discovered during a shoulder arthroscopy on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the attachment during use.

• Brand Name: BLURR, 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: 20569596
• Report Number: 1220246-2024-08338
• Device Sequence Number: 12632727
• Product Code: GFF
• UDI-Device Identifier: 00888867043749
• UDI-Public: (01)00888867043749(11)240506(17)290430(10)15244005
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 07/08/2025

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: BLURR, 5.0MM X 13CM
• Device Catalogue Number: AR-8500BL
• Device Lot Number: 15244005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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