MAUDE Adverse Event Report: ARTHREX, INC. 2.5 MM DRILL, BIT, CALIBRATED; BIT, DRILL

Catalog Number	AR-8943-42
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The evaluation revealed that the distal tip of the drill was sheared off.Furthermore, indentations and tool marks were observed on the cutting flutes.The device met all material specification as received.Complainant's event is typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is obtained from the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a triple arthrodesis procedure, the surgeon was drilling into the patient's talus with a 2.5mm calibrated drill bit.While drilling into the talus for a 3.5 non-locking cortical screw, the drill tip broke-off.The tip (1 cm) of the drill was unable to be retrieved.The surgeon re-drilled in a new trajectory to place the 3.5 non-locking cortical screw.

• Brand Name: 2.5 MM DRILL, BIT, CALIBRATED
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6555582
• Report Number: 1220246-2017-00158
• Device Sequence Number: 11082431
• Product Code: HTW
• UDI-Device Identifier: 00888867052499
• UDI-Public: 00888867052499
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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: Health Professional
• Device Catalogue Number: AR-8943-42
• Device Lot Number: 031418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 150