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

Model Number	1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/6/2023, it was reported by a sale representative via email that a hip 1.8mm drill broke in half.No further information has been reported.Additional information received on 6/6/2023: an ar-3600d-2h 1.8mm drill for hip fibertak broke during reaming inside the patient.This was discovered during a labral repair procedure on (b)(6) 2023.All the broken fragments were retrieved and a new ar-3600d-2h 1.8mm drill for hip fibertak was used to complete the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: 1.8MM DRILL BIT, 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: emily shafer ; 8009337001
• MDR Report Key: 17246525
• Report Number: 1220246-2023-07015
• Device Sequence Number: 5259654
• 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): 12/09/2024

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
• Device Lot Number: 022315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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