MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 12 FLUTE 5.5MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 12 FLUTE 5.5MM X 13CM
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2021
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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Device discarded.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces and /or improper assembly when connecting to the handpiece.
Event or Problem Description
On 09/24/2021 it was reported by a sales representative via sems that an ar-8550obt oval burr, will not detach from the shaver hand piece.Ts: physical.

• Brand Name: BURR, OVAL, 12 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: 19451720
• Report Number: 1220246-2024-04773
• Device Sequence Number: 12958162
• Product Code: GFF
• UDI-Device Identifier: 00888867044050
• UDI-Public: 00888867044050
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• 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 Model Number: BURR, OVAL, 12 FLUTE 5.5MM X 13CM
• Device Catalogue Number: AR-8550OBT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown