MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS IMRI MOTOR; MOTOR, DRILL, PNEUMATIC - HANDPIECE

Catalog Number IMRI-MOTOR_LL

Device Problems Material Deformation (2976); Scratched Material (3020); Temperature Problem (3022)

Patient Problem Injury (2348)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

This is report 3 of 3 for the same event.It was reported that during a burr hole craniotomy surgery, it was observed that the motor device and attachment device were heating up when in use with a burr device.According to the report, after examination, it was observed that the attachment device ¿marred¿ the burr device.It was further reported that dark ¿scorch marks¿ were observed on the burr device.As a result, there was a three minute delay to the surgical procedure.It was reported that spare devices were available for use.There was patient involvement.There were reports of injuries, medical intervention or prolonged hospitalization.The reporter was unable to determine which device caused the alleged malfunction.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.An assessment was performed and the device met all temperature specifications.Therefore, an assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: IMRI MOTOR
• Type of Device: MOTOR, DRILL, PNEUMATIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4248893
• MDR Text Key: 5048189
• Report Number: 1045834-2014-14815
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IMRI-MOTOR_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTACHMENT DEVICE; BURR DEVICE