MAUDE Adverse Event Report: ARTHREX, INC. 2.0MM DRILL BIT, CALIBRATED, REUSABLE; BIT, DRILL

Model Number	2.0MM DRILL BIT, CALIBRATED, REUSABLE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2021
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 foot surgery the drill bit die break off while drilling.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.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.No further information received.
Additional Manufacturer Narrative
Complaint confirmed, the device broke close to the proximal end where the orange-coated section is.The device was also found to be bent and the edges of the flute are dented and worn.Evidence indicates a likely cause of the breakage is prying/leveraging the device during use.

• Brand Name: 2.0MM DRILL BIT, CALIBRATED, REUSABLE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12300536
• Report Number: 1220246-2021-03496
• Device Sequence Number: 17188878
• Product Code: HTW
• UDI-Device Identifier: 00888867265752
• UDI-Public: 00888867265752
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 2.0MM DRILL BIT, CALIBRATED, REUSABLE
• Device Catalogue Number: AR-8943-16-RU
• Device Lot Number: 032107
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1