MAUDE Adverse Event Report: BIOMET 3I; DENTAL DRIVER

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2022

Event Type  malfunction  

Event Description

It was confirmed that the driver does not take the implant and it fells to the ground.The affected dental position is: unknown.The doctor confirmed that the procedure was concluded.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Patient weight unknown / not provided.Brand name unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The unknown biomet driver was not returned.Visual evaluation of the as returned product identified no damage/malfunction with the implant.Functional testing to recreate the reported event; verified the implant engaged and retained with an in-house driver as intended.A pre-existing condition noted on the per was low bone density (type iii).The reported implant was located on an unknown tooth site (fdi) and was used, placed and removed on the same day.Device history record (dhr) review and complaint history review by lot number could not be performed, as the lot number associated with the reported product (unknown biomet driver) is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Based on the available information, the driver malfunction could not be verified.Therefore, the reported event was non-verifiable.

• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15074410
• MDR Text Key: 298963918
• Report Number: 0001038806-2022-01100
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male