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	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during an ankle fusion procedure, while the surgeon was under drilling the "home run screw" hole in the anterior ankle fusion plate, the 3.0mm calibrated drill tip broke off inside the patient's talus.The tip was unable to be retrieved from the bone.Proceeding, a 5.5 cancellous screw was placed the same "home run screw" hole with the tip of the drill remaining in the patient.The surgeon placed the 5.5 cancellous screw to try and push the drill tip through the talus and out of the calcaneal, but this was not achieved.The tip stayed in the patient.

• 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
• MDR Report Key: 8739522
• Report Number: 1220246-2019-01186
• Device Sequence Number: 2566003
• Product Code: HWE
• UDI-Device Identifier: 00888867133860
• UDI-Public: 00888867133860
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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?: No
• Operator of Device: No Information
• Device Model Number: CALIBRATED DRILL BIT, 3.0MM
• Device Catalogue Number: AR-8970-30
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other