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

Catalog Number IIPDTUL

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported that the driver was not disengaging from the implant.They also do not have information on which implants were used but they were not engaging mostly with 3.8 platform (purple/micromini) implants.Clinician was were able to complete them with different tools.Tooth location not reported.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Manufacturer Narrative

One (1) internal connection universal placement driver tip - long (iipdtul) was returned for investigation.The unknown implant was not returned.Visual evaluation of the as returned product identified the driver was able to engage, retain and disengage an applicable in-house mating implant as normal during functional testing.No pre-existing condition was noted, and no per form was provided.Bone density type is unknown.The reported implant was located on an unknown tooth site, and was used for an unknown amount of time.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to prevent the distribution of non-conforming product is within specifications.A complaint history review by item number was conducted for the (iipdtul) 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.Complaint history review could not be performed for the unknown implant since the lot/item number was unknown.Based on the available information, driver malfunction did not occur and implant malfunction could not be verified.Therefore, the reported event was non-verifiable.The following sections have been updated: h3: changed "no" to "yes".

Event Description

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

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• 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: 13114719
• MDR Text Key: 283164961
• Report Number: 0001038806-2021-02424
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose