MAUDE Adverse Event Report: BIOMET 3I DO NOT USE - OSSEOCISION TM 20:1 HANDPIECE

Catalog Number SGM-E20RI

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 01/15/2020

Event Type  Injury  

Event Description

It was reported that the piece at the top of the handpiece did not allow drills to engage and the handpiece would not spin.The patient was under anesthesia and the dentist was unable to complete the procedure.The patient was sent home and will return at a later date.

• Brand Name: DO NOT USE - OSSEOCISION TM 20:1 HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9693527
• MDR Text Key: 178583381
• Report Number: 0001038806-2020-00311
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGM-E20RI
• Device Lot Number: A7300100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2020
• Distributor Facility Aware Date: 01/15/2020
• Event Location: Other
• Date Report to Manufacturer: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention