MAUDE Adverse Event Report: ARTHREX, INC. 4.0MM DRILL BIT, CANNULATED, REUSABLE; BIT, DRILL

Model Number	4.0MM DRILL BIT, CANNULATED, REUSABLE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/04/2023
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 fusion surgery the surgeon was drilling the tibia for a ankle fusion.He hit a metal screw already implanted and the drill bit snapped at the tip.A different drill was used to complete the case.A small part of the drill stayed in the patient and the surgeon and hospital were happy with the outcome.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 4.0MM DRILL BIT, CANNULATED, REUSABLE
• Common Device Name: BIT, DRILL
• 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: 16223441
• Report Number: 1220246-2023-06157
• Device Sequence Number: 20409833
• Product Code: HTW
• UDI-Device Identifier: 00888867265776
• UDI-Public: 00888867265776
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 01/23/2023

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: 4.0MM DRILL BIT, CANNULATED, REUSABLE
• Device Catalogue Number: AR-8970-40C-RU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown