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

Catalog Number IIPDTUL

Device Problem Separation Failure (2547)

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

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint number (b)(4).Age and date of birth unknown / not provided.Lot number unknown / not provided.Udi not available.First/given name: unknown / not provided.Last name unknown / not provided.Pma/510(k) number not available.

Event Description

It was reported that t the driver tip could not disengage from implant.Implant removed.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).One (1) internal connection universal placement driver tip - long (iipdtul) was not returned for investigation.Visual evaluation could not be performed.Functional testing was performed with an in-house placement driver.The implant engaged and disengaged the implant as intended.A pre-existing condition noted on the per form was unknown.Bone density was low density (type iii).The reported device was located on tooth location # 33 (unknown dental notation system) and was used for approximately one (1) month.Dhr review could not be performed since the lot numbers associated to the items were not provided.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the iipdtul dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformance's/capa/hhe/d/ie/product holds for the reported product for similar event.Review completed utilizing keywords: functional : does not disengage/release therefore, based on the available information, device malfunction could not be verified (implant driver) and the reported event was non-verifiable.

• 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: 16156434
• MDR Text Key: 307260682
• Report Number: 0001038806-2023-00065
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTUL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/02/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: BNSS411 LOT 2021010834
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG