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

Model Number	1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 01/25/2023, it was reported by a sales representative via phone that a ar-3600d-2h drill, for hip fibertaks tip broke off.This occurred during a hip scope.No additional information provided.Additional information requested.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is a user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: 1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
• Common Device Name: BIT, DRILL
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16361748
• Report Number: 1220246-2023-06267
• Device Sequence Number: 7544346
• Product Code: HTW
• UDI-Device Identifier: 00888867298019
• UDI-Public: 00888867298019
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/30/2024

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 BIT, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3600D-2H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown