MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX MR8; DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)

Model Number MR8-9MC30

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Surgeon needed to remove screws that patient previously had from when he was younger.While trying to remove screws a midas rex metal cutting burr sheared off while being used as well as a sleeve from synthes broken screw removal set.X-ray notified, broken pieces removed from field.X-rays taken - radiologist confirmed no unexpected findings.Surgeon evaluated and reviewed films as well.No harm to the patient.

• Brand Name: MIDAS REX MR8
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 826 coal creek circle; ms ss-54; louisville CO 80027
• MDR Report Key: 15995131
• MDR Text Key: 305603592
• Report Number: 15995131
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00763000506742
• UDI-Public: (01)00763000506742
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MR8-9MC30
• Device Lot Number: 0224091425
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male