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

Model Number	BURR, ROUND, 8 FLUTE 5.0MM X 13VM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint allegation was not confirmed.Per the event description, it is concluded that the failure of the device can be related to an internal manufacturing process issue identified on the ncr-24360.However, without the return of the device, the complaint allegation cannot be confirmed.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8500rbe burr broke off in the shaver handpiece while it was being used.It was working fine for a few minutes and then the surgeon felt ¿rattling¿ and it was noticed a shard had broken off.The burr was disposed of.Patient was not affected.

• Brand Name: BURR, ROUND, 8 FLUTE 5.0MM X 13VM
• 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: 19568987
• Report Number: 1220246-2024-06182
• Device Sequence Number: 12311318
• Product Code: GFF
• UDI-Device Identifier: 00888867043879
• UDI-Public: 00888867043879
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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 5.0MM X 13VM
• Device Catalogue Number: AR-8500RBE
• Device Lot Number: 15045288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown