MAUDE Adverse Event Report: ARTHREX, INC. 1.7MM DRILL BIT, REUSABLE

Model Number	1.7MM DRILL BIT, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint is confirmed.The complaint is confirmed based on the customer provided photo, which displays the damage of the broken drill.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.
Event or Problem Description
It was reported that during a jones fracture surgery the drill broke and a piece of it stayed inside the patient bone, because the doctor chose not to take it out.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.
Additional Manufacturer Narrative
Complaint is confirmed.The complaint is confirmed based on the customer provided photo, which displays the damage of the broken drill.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: 1.7MM DRILL BIT, 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: vik bajnath ; 8009337001
• MDR Report Key: 16809895
• Report Number: 1220246-2023-06585
• Device Sequence Number: 6105821
• Product Code: HTW
• UDI-Device Identifier: 00888867272682
• UDI-Public: 00888867272682
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1.7MM DRILL BIT, REUSABLE
• Device Catalogue Number: AR-8916-14-RU
• Device Lot Number: 032016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown