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

Model Number	1.8MM DRILL FOR FIBERTAK
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation was not confirmed.Visual evaluation on the returned device showed did not showed any abnormalities.As stated in the event description device work as intended.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.
Event or Problem Description
On 09/30/2021, it was reported by a sales representative via e-mail that while the surgeon was performing a labral repair on (b)(6) 2021, quantity 6 of an ar-3638, lot: 13255279, pull out at various points during the implanting/tension process.The surgeon also used the reusable curved guide with the 1.8mm drill, ar-3600nd-2, lot: 12691838, cycling multiple times as recommended and pulling back to set the anchor.The case was completed by drilling new spots and placing new ar-3638 from a different lot.

• 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: 19484528
• Report Number: 1220246-2024-05235
• Device Sequence Number: 12739133
• Product Code: HTW
• UDI-Device Identifier: 00888867101982
• UDI-Public: 00888867101982
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 01/31/2026
• Device Model Number: 1.8MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600ND-2
• Device Lot Number: 12691838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown