MAUDE Adverse Event Report: ARTHREX, INC. CALIBRATED DRILL BIT, 3.0MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	CALIBRATED DRILL BIT, 3.0MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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 a ankle arthrodesis the drill broke off.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.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the broken drill.The drill broke at the distal end of the shaft and beginning of the flute.However, without return of the device for physical evaluation, the cause remains undetermined.A likely causes are improper bone prep, misaligned insertion, prying and/or leveraging the device.

• Brand Name: CALIBRATED DRILL BIT, 3.0MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 12696590
• Report Number: 1220246-2021-03831
• Device Sequence Number: 17300572
• Product Code: HWE
• UDI-Device Identifier: 00888867133860
• UDI-Public: 00888867133860
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: CALIBRATED DRILL BIT, 3.0MM
• Device Catalogue Number: AR-8970-30
• Device Lot Number: 0319020086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 05/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown