MAUDE Adverse Event Report: BIOMET 3I; DENTAL DRIVER

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Catalog and lot number unknown / not provided.Udi not available.Pma/510(k) number not available.

Event Description

It was reported that implant disengaged from insertion device.Patient did not suffer any consequence form the event as the procedure was completed with another implant and device.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).One osseotite® certain® 2 implant 4 x 10mm was returned for investigation.However, one unknown biomet driver was reported but not returned.Visual evaluation of the as returned products identified some signs of use, but no apparent signs of malfunction.Functional testing was performed using applicable in-house driver.The device was able to engage, retain and disengage as normal.Device history record (dhr) review could not be performed for the driver as the item/lot number was unknown.Complaint history for the unknown biomet driver could not be performed as the item/lot number was unknown.November post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information and functional testing, implant malfunction did not occur.However, driver malfunction and the reported event could not be verified since the driver was not returned.

Event Description

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

• 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: 12369503
• MDR Text Key: 268196938
• Report Number: 0001038806-2021-01610
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1