MAUDE Adverse Event Report: BIOMET 3I; DENTAL DRIVER

Device Problem Fracture (1260)

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

Event Date 03/26/2023

Event Type  malfunction  

Event Description

It was reported that when tigheting the implant the driver fractured inside, the implant had to be removed.Implant had fractured at the collar as well.Other implant placed.

Manufacturer Narrative

Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.D1: brand name unknown / provided.D4: additional device information unknown / not provided.D10.Concomitant medical products and therapy dates, t3pt5411, t3 pro tapered implant.5/4mm (d) x 11.5mm (l), 2023061320.G4: premarket identification unknown / not provided.H4: device manufacturer date unknown / not provided.Since the lot number and device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.

• 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 ; 5619713230
• MDR Report Key: 18303356
• MDR Text Key: 330463368
• Report Number: 0001038806-2023-02393
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: NL
• Exemption Number: 5645646
• 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
• Report Date: 12/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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 Device Evaluated by Manufacturer?: No
• 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
• Treatment: DENTAL IMPLANT
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic