MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 8 FLUTE 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/25/2021, it was reported by an arthrex employee via sems that an ar-8400obe burr created debris while inside the patient, around the acromion area of the scapula.This was discovered during a shoulder arthroscopy on (b)(6) 2021.Additional information requested.
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.Per (b)(4), item ar-8400obe batch 13581969 (1qty.) was discarded by the facility.The complaint device was not received for evaluation.Based off the information provided, the most likely cause of this condition is the excessive force used to pry and/or leverage the device.

• Brand Name: BURR, OVAL, 8 FLUTE 4.0MM 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: 19446935
• Report Number: 1220246-2024-04695
• Device Sequence Number: 8539878
• Product Code: GFF
• UDI-Device Identifier: 00888867043602
• UDI-Public: 00888867043602
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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 Expiration Date: 05/31/2026
• Device Model Number: BURR, OVAL, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400OBE
• Device Lot Number: 13581969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown