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 Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2023
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 during an ankle sprain surgery the surgeon noticed after the screw was placed that the drill bit fragment.The fragment remained in the patient's body, due to the mini-invasive type of procedure, it was not possible to extract the broken piece.It was not necessary to switch the surgical technique or no second surgery was performed.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the distal end of the flutes broken.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force, misaligned insertion and/or prying/leveraging the device during use.
Event or Problem Description
Update dw 22-jan-2024: further information were provided that the surgery was finished successfully without any complications.Surgeon saw the small fragment which remained inside of the patient when he made last control x-ray screening in the end of the surgery.There was no chance to remove the fragment because the surgeon already sutured up the incision.

• 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: 18394862
• Report Number: 1220246-2023-09625
• Device Sequence Number: 11435621
• Product Code: HTW
• UDI-Device Identifier: 00888867319592
• UDI-Public: 00888867319592
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 06/13/2024

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
• Device Lot Number: 032242
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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