MAUDE Adverse Event Report: MEDTRONIC XOMED, INC.; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

The drill bit adapter for the midas rex surgical drill failed while in use.There was no harm to the patient.The drill bit adapter was removed from service and given to the materials coordinator.Another midas rex drill was obtained.The physician was aware of the incident.

• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpointe drive north; jacksonville FL 32216
• MDR Report Key: 4643626
• MDR Text Key: 5600545
• Report Number: 4643626
• Device Sequence Number: 1
• Product Code: GFF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 69