MAUDE Adverse Event Report: BIOMET 3I; DENTAL DRIVER

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Device was not returned.

Event Description

It was reported that during implant placement while transferring the implant into patient mouth, an unknown biomet driver disengaged the implant prior placement and implant dropped on the floor.Procedure could not be completed.

Event Description

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

Manufacturer Narrative

The reported unknown biomet driver was not identified, and was not returned for inspection.However, one 3i t3® with dcd® non-platform switched tapered implant 5 x 10mm (bnst510) was returned for investigation.Functional testing was performed for the implant and it was determined the implant was noted to assemble and retain with a mating house driver.Pre-existing patient factors, implant age, tooth location are not relevant to the reported event.Dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review could not be performed without relevant item and lot information.November post market trending was reviewed and there were no negative trends or corrective actions for the reported events (disassembled components & lack of retention) or product (biomet implant drivers & bnst510).Functionality of the reported driver could not be verified without the product.Therefore, the reported event could not be verified.

• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9328297
• MDR Text Key: 166956989
• Report Number: 0001038806-2019-01396
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention