MAUDE Adverse Event Report: BIOMET 3I MOTOR WITH CABLE

Catalog Number 04720022

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Customer reported that the handpiece stopped working mid surgery.It stopped spinning not allowing him to completed the implant.The patient was not under any anesthesia.They used nitrous instead.The site was grafted.

Event Description

No further event information available at the time of this report.

• Brand Name: MOTOR WITH CABLE
• Type of Device: MOTOR
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10379792
• MDR Text Key: 202075915
• Report Number: 0001038806-2020-01108
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/07/2020,09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04720022
• Device Lot Number: S/N E06065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 08/07/2020
• Distributor Facility Aware Date: 07/27/2020
• Event Location: Other
• Date Report to Manufacturer: 08/07/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention