MAUDE Adverse Event Report: BIOMET 3I CERTAIN UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (SHORT); DENTAL DRIVER TOOL

Catalog Number IRE100U

Device Problem Separation Failure (2547)

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

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).D10.Implant: bopt5410, 3i t3 tapered implant 5/4 x 10mm / 2022080167; d10: healing abutment: ieeha465, certain bellatek encode emergence healing abutment 4.1mm(d) 6mm(p) 5mm(h)/1270869; product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported placing the implant using the ire100u driver by hand the driver stripped and the implant was short of full seating at tooth site #30.The healing abutment also was unable to be seated to the implant.The reporter did not trust either the implant or the healing abutment at that point so both the implant and the healing abutment were removed.A new implant and healing abutment were placed, and a new driver was ordered.

• Brand Name: CERTAIN UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (SHORT)
• Type of Device: DENTAL DRIVER TOOL
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18673710
• MDR Text Key: 334982787
• Report Number: 0001038806-2024-00200
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2024

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
• Device Catalogue Number: IRE100U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANT BOPT5410 AND HEALING ABUTMENT IEEHA465
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic