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

Catalog Number IIPDTUL

Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that after the doctor completed the osteotomy, the implant was unable to be screwed into the bone.Implant placement will be reattempted in 4-6 months.The gemlock driver would just free spin when in use.

Manufacturer Narrative

Zimmer biomet (b)(4).Patient weight not provided.Lot number not provided.Manufacturing date is unknown.

Manufacturer Narrative

One (1) internal connection universal placement driver tip - long (iipdtul) was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was moderate bone density (type ii).The reported device was located on tooth # 30 (universal) and was placed and removed on the same day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev h - 07/2021 -- instructions for use for biomet 3i kits and instruments (p-zbdinstrp) rev.D - sep 2020.Information identified: warnings and precautions.Per the applicable ifu, it is stated that surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including prolonged use, misuse, and rough or improper handling.Care must be taken to avoid compromising their performance.However, dhr review could not be performed for the iipdtul driver as the lot number was unknown.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.Post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged drive feature) or product (iipdtul).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.

Event Description

There is no update to the original complaint description provided.

• 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: 12982879
• MDR Text Key: 282097262
• Report Number: 0001038806-2021-02348
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/27/2022

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: 11/16/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/27/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female