MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM DRILL FOR FIBERTAK; DRILL BIT

Model Number	1.8MM DRILL FOR FIBERTAK
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
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 device was not received for evaluation; no photos were provided.Per the event description, the most likely cause(s) of the reported failure are using error, misaligned insertion, and prying/leveraging the device.The complaint allegation cannot be confirmed without the device for evaluation.
Event or Problem Description
On 05/18/2023, it was reported by a sales representative via sems that an ar-3600d-2 drill got bound up in the ar-3610st drill sleeve.This was discovered during a case with no patient effect.

• Brand Name: 1.8MM DRILL FOR FIBERTAK
• Common Device Name: DRILL BIT
• 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: 19505286
• Report Number: 1220246-2024-05477
• Device Sequence Number: 6932662
• Product Code: HTW
• UDI-Device Identifier: 00888867101913
• UDI-Public: 00888867101913
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 1.8MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600D-2
• Device Lot Number: 14968916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown