MAUDE Adverse Event Report: ARTHREX, INC. 4.5MM QUICK RELEASE DRILL; MANUAL INSTR, GENERAL SURGICAL

Model Number	4.5MM QUICK RELEASE DRILL
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/18/2022 it was reported by a sales representative via (b)(4) that the ar-9239 drill bit is dull and has a metal ring spur.This was discovered during use in a eclipse tsa on (b)(6) 2022.The case was completed using the same device.
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 device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure is wear and tear.

• Brand Name: 4.5MM QUICK RELEASE DRILL
• Common Device Name: MANUAL INSTR, GENERAL 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: 19318421
• Report Number: 1220246-2024-03285
• Device Sequence Number: 15368534
• Product Code: MDM
• UDI-Device Identifier: 00888867059528
• UDI-Public: 00888867059528
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/15/2024

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: 4.5MM QUICK RELEASE DRILL
• Device Catalogue Number: AR-9239
• Device Lot Number: 0038670595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown