MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 8 FLUTE 5.5MM X 13CM; BURR,SURGICAL

Model Number	BURR, ROUND, 8 FLUTE 5.5MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/26/2024, it was reported by a facility representative via sems (b)(4) that two (qty.2) ar-8550rbe round burr attachments were broken in the hub at the attachment connection.This occurred during use in a case with no patient impact.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8550rbe serial/batch number (b)(6) was received for investigation.Functional testing could not be conducted because the connector hub was damaged internally.A visual inspection revealed that the connector hub is broken internally.The most likely cause of the reported failure is the application of excessive force during use.

• Brand Name: BURR, ROUND, 8 FLUTE 5.5MM 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: 19740051
• Report Number: 1220246-2024-06736
• Device Sequence Number: 7785636
• Product Code: GFF
• UDI-Device Identifier: 00888867044074
• UDI-Public: 00888867044074
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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, 8 FLUTE 5.5MM X 13CM
• Device Catalogue Number: AR-8550RBE
• Device Lot Number: 15213867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2024
• 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