MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX LEGEND TIP; MOTOR, DRILL, PNEUMATIC

Lot Number 0224147531

Device Problem Break (1069)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

Midas rex tip broke into two pieces during orthopedic procedure.All pieces retrieved.Fda safety report id# (b)(4).

• Brand Name: MIDAS REX LEGEND TIP
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS
• MDR Report Key: 15183481
• MDR Text Key: 297515173
• Report Number: MW5111306
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/03/2022

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 Lot Number: 0224147531
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White