MAUDE Adverse Event Report: BIOMET 3I ZIMMER MOTOR SYSTEM 115V

Catalog Number 00900125

Device Problem No Device Output (1435)

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

Event Date 09/10/2019

Event Type  Injury  

Event Description

It was reported that during a procedure when drilling the osteotomy, the water light comes on the display, and the motor stops working.The doctor placed a bone graft and the patient had to return to complete the procedure.

• Brand Name: ZIMMER MOTOR SYSTEM 115V
• Type of Device: MOTOR
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9295187
• MDR Text Key: 165570262
• Report Number: 0001038806-2019-01306
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2019,11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00900125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2019
• Distributor Facility Aware Date: 09/10/2019
• Event Location: Other
• Date Report to Manufacturer: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention