MAUDE Adverse Event Report: MEDTRONIC POWER SURGICAL SOLUTIONS MIDAS REX

Lot Number P04221269AS08

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2016

Event Type  malfunction  

Event Description

During craniotomy procedure, wire passer tip broke off from midas rex pneumatic drill on pt's right side of skull.A second drill bit was obtained and it too broke off at the tip.Flew across operating room away from the surgical field.Reason for use: craniotomy.Is the product compounded? no.Is the product over-the-counter? no.Event abated after use stopped or dose reduced? no.Event abated after use stopped or dose reduced? no.Event reappeared after reintroduction? yes.

• Brand Name: MIDAS REX
• Type of Device: MIDAS REX
• Manufacturer (Section D): MEDTRONIC POWER SURGICAL SOLUTIONS; ft. worth TX 76137
• MDR Report Key: 5744454
• MDR Text Key: 48250262
• Report Number: MW5062975
• Device Sequence Number: 1
• Product Code: HBB
• 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: 06/20/2016
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: P04221269AS08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1