MAUDE Adverse Event Report: ARTHREX, INC. 5.0MM, DRL BIT, CANNULATED, REUSABLE; DRILL BIT

Model Number	5.0MM, DRL BIT, CANNULATED, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
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
It was reported that the drill broke during subtalar arthroscopy when over-drilling the k-wire and applying force in the ao junction within the approach.The surgeon thought that the drill was blunt and therefore he had to apply more force.However, the force applied was not so strong that the drill could have broken.The other drill, which appeared to be sharper, was then used without any problems.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update nroe 15-dec-2023: further information revealed that a small part stuck in the attachment.The main part was retrieved off the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual inspection identified the male fitting of the 5.0 mm drill bit, cannulated, reusable had broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: 5.0MM, DRL BIT, CANNULATED, REUSABLE
• 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: 18474026
• Report Number: 1220246-2024-00204
• Device Sequence Number: 6407987
• Product Code: HTW
• UDI-Device Identifier: 00888867319592
• UDI-Public: 00888867319592
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 12/11/2024

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: 5.0MM, DRL BIT, CANNULATED, REUSABLE
• Device Catalogue Number: AR-8770-02-RU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown