MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC ELECTRIC BONE MILL

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  Other  

Event Description

Medtronic midas rex electric bone mill cleaning instruction does not specify how to remove neutral enzymatic detergent before drying and sterilization.Residual enzymatic detergent could trigger an inflammatory response in a patient exposed during surgery.Medtronic was contacted and stated they have no plans to modify or update the ifu.They know they have not provided a method to rinse the detergent from their device.

• Brand Name: MEDTRONIC ELECTRIC BONE MILL
• Type of Device: ELECTRIC BONE MILL
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 3685250
• MDR Text Key: 20266239
• Report Number: MW5034945
• Device Sequence Number: 1
• Product Code: LYS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2014
• Patient Sequence Number: 1