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.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).H10: additional narrative.Zimvie received one (1) unknown biomet driver for evaluation.Visual evaluation was performed, a fractured driver fragment was identified inside implant.Device history record (dhr), sterilization, and complaint history review could not be performed, as the subject lot number associated with the unknown biomet driver is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was summary of failure(s).Therefore, based on the available information, a device malfunction did occur.A fractured driver fragment was identified inside implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• 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,Followup
• Report Date: 05/07/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic