MAUDE Adverse Event Report: ARTHREX, INC. DRILL FOR HTO TITANIUM SCREWS; DRILL BIT

Model Number	DRILL FOR HTO TITANIUM SCREWS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2023
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 9/27/2023, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-13319 drill for hto titanium screws had an issue during a tibial osteotomy procedure on (b)(6) 2023.The drill broke during the procedure, the surgeon used another available drill to complete the surgery successfully.No piece broke off inside the patient.This occurred during use with no patient harm.Additional information has been requested.On 10/2/2023, the arthrex subsidiary employee provided the following information via email: the drill was inside the patient when it broke.All fragments were retrieved.The bone quality of the patient was not provided.There was no case delay reported.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which shows that the flutes of the drill had broken.The most likely cause for the reported failure can be attributed to a user error of the device due to misalignment insertion and/or prying/leveraging the device during insertion.
Additional Manufacturer Narrative
The complaint allegation is confirmed.Upon visual inspection, it was noted that the shaft of the drill for hto titanium screws had broken off.Dimensional testing was performed, and the dimension ø.126 ±.001 was between tolerance.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage in the field.Manufacturing date 2019.

• Brand Name: DRILL FOR HTO TITANIUM SCREWS
• 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: 17957457
• Report Number: 1220246-2023-08238
• Device Sequence Number: 12042043
• Product Code: HWE
• UDI-Device Identifier: 00888867011236
• UDI-Public: 00888867011236
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: DRILL FOR HTO TITANIUM SCREWS
• Device Catalogue Number: AR-13319
• Device Lot Number: 011912
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 07/02/2024; 10/09/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 08/01/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown