MAUDE Adverse Event Report: BIOMET 3I UNKNOWN BIOMET PLACEMENT DRIVER; DENTAL DRIVER

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that before implant placement, the implant was dropped from the driver.The procedure was completed using another implant.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Manufacturer Narrative

The unknown driver, was not returned.Visual evaluation of the as returned product identified the implant with signs of use.No malfunction.Functional testing to recreate the reported event with an in-house driver identified no issues with the returned implant.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev i - 2022/04/01.Information identified: warnings precautions potential adverse events and instructions for use for biomet 3i kits and instruments (p-zbdinstrp), rev e 2022/04/01; information identified: warnings and precaution.Dhr review: unknown driver.Dhr review and complaint history review could not be performed, as the lot number associated with the reported product (unknown driver) is not available.Zimmer biomet quality management system (qms) has controls in place to prevent the distribution of non-conforming product is within specifications.Post market trend review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional : disengaged) or product (bost511, unknown driver).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur for the returned implant, and could not be verified for the unknown driver since, it was not returned.The reported event was non-verifiable.Sections updated: b4: date of this report.G3: date investigation results were received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated.H6: adverse event problem codes.

Event Description

There is no update to the original complaint description provided.

• Brand Name: UNKNOWN BIOMET PLACEMENT DRIVER
• 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: 13061145
• MDR Text Key: 284687334
• Report Number: 0001038806-2021-02411
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

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: 11/30/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/14/2022
• 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
• Patient Age: 21 YR
• Patient Sex: Prefer Not To Disclose