MAUDE Adverse Event Report: ORCHID UNIQUE HELIOCOIDAL RASP. ; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number 5130-080-030

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/14/2020

Event Type  malfunction  

Event Description

Physician was performing a revision tka.To remove the old implants, physician was using a metal cutting helicoidal rasp.(#5130-080-030).While using, five of them broke.All pieces were retrieved from the knee and an x-ray was taken in the operating room to confirm placement of new implants and to confirm there was no metal from the rasps retained in the knee.Fda safety report id# (b)(4).

• Brand Name: HELIOCOIDAL RASP.
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): ORCHID UNIQUE
• MDR Report Key: 9744490
• MDR Text Key: 180890536
• Report Number: MW5093194
• Device Sequence Number: 4
• Product Code: HBE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2020
• 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: No Information
• Device Model Number: 5130-080-030
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR