MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 4.5MM CANNULATED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DRILL, 4.5MM CANNULATED
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
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 is expected but not returned for evaluation.The 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 procedure, as the surgeon was drilling with the 4.5 mm cannulated drill, the tip broke off and was unable to be retrieved from the joint.Reporter has no further details.Additional information provided 7/25/2018: surgeon tried to retrieve the tip of the drill, but he decided to leave the broken fragments in patient body.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed that the distal tip of the 4.5mm cannulated drill had broken off proximal to the 15mm laser mark.The breakage point was noted to be uneven, with metal gouges along the id of the cannulated drill.On the device there are no signs of failures from prying/leveraging or torquing.The cause of the event is unknown.

• Brand Name: DRILL, 4.5MM CANNULATED
• 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: 7781840
• Report Number: 1220246-2018-00594
• Device Sequence Number: 1835345
• Product Code: HWE
• UDI-Device Identifier: 00888867087781
• UDI-Public: 00888867087781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: DRILL, 4.5MM CANNULATED
• Device Catalogue Number: AR-1218-45
• Device Lot Number: 11749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 11/30/2018
• 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