MAUDE Adverse Event Report: ARTHREX, INC. 2.2 MM DRILL BIT, COMP FT, CALIBRATED; ARTHROSCOPIC ACCESSORIES

Model Number	2.2 MM DRILL BIT, COMP FT, CALIBRATED
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2021
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force being applied during use.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per wi-000100100.
Event or Problem Description
On 9/3/2021 it was reported by a sales representative vie email that ar-8737-58 2.2 mm drill bit, comp ft, calibrated got stuck in ar-8737-43 drill guide, percutaneous.This was discovered during a metacarpal fracture procedure by dr.(b)(6).Additional information updated 9/7/2021 case was completed using another drill from the tray and not using a guide.The drill was not ale to be removed from the guide until after the case.Since grill was discarded devices will not be returning.

• Brand Name: 2.2 MM DRILL BIT, COMP FT, CALIBRATED
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 19318822
• Report Number: 1220246-2024-03292
• Device Sequence Number: 6335380
• Product Code: NBH
• UDI-Device Identifier: 00888867253148
• UDI-Public: 00888867253148
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2.2 MM DRILL BIT, COMP FT, CALIBRATED
• Device Catalogue Number: AR-8737-58
• Device Lot Number: 1392114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown