MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM FLEX DRILL, KNOTLESS HIP FIBERTAK; DRILL BIT

Model Number	1.8MM FLEX DRILL, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the drill was shearing bits off in the reusable sleeve.The surgeon opened a new ar-3600nd-2h without further issue.Additional information provided: procedure being performed was a labral repair.No fragments broke off.The case was completed by using a different anchor system ar-1938bc.
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 due to the drill coming in contact with other instrument during use.

• Brand Name: 1.8MM FLEX DRILL, KNOTLESS HIP 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: 19319080
• Report Number: 1220246-2024-03298
• Device Sequence Number: 7592041
• Product Code: HTW
• UDI-Device Identifier: 00888867298026
• UDI-Public: 00888867298026
• 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: 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 Expiration Date: 11/30/2025
• Device Model Number: 1.8MM FLEX DRILL, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3600ND-2H
• Device Lot Number: 12213282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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