MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT; DENTAL DRIVER

Catalog Number IIPDTUS

Device Problem Separation Failure (2547)

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

Event Date 11/21/2022

Event Type  Injury  

Event Description

It was reported that tool cannot be disengaged from the implant at tooth site 27.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi 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).One (1) internal connection universal placement driver tip - short (iipdtus) and one (1) 3i t3 with dcd non-platform switched parallel walled implant 4 x 10mm (bnss410) were returned for investigation.Visual inspection of the as returned products identified bone debris on external threads.Functional testing was performed for the returned products.It was confirmed that the implant and placement driver would not disengage from each other.Malfunction.Pre-existing conditions were not noted on the per form.Bone density was unknown.The reported device had been placed on tooth #43 (fdi).Dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported product are 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 by item number was conducted for the (iipdtus) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Review completed utilizing keywords: functional : does not disengage/release.Based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - SHORT
• 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: 16054797
• MDR Text Key: 306240430
• Report Number: 0001038806-2022-01982
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG