MAUDE Adverse Event Report: BIOMET 3I CERTAIN® 4, 5, 6MM(D) IMPLANT DRIVER TIP - SHORT; DENTAL IMPLANT DRIVER

Catalog Number IIPDTS

Device Problem Separation Failure (2547)

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

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Manufacturing date of device is unknown.

Event Description

I was reported that the device would not disengage from the implant at the time of placement.The procedure was able to be completed using another device.

Manufacturer Narrative

Zimvie complaint number (b)(4).One driver tip was returned for investigation.No apparent signs of malfunction were identified for the iipdts.Additionally, one unknown biomet implant was reported but not returned for the investigation.Functional testing was performed for the iipdts which engaged and disengaged with in-house mating implant as normal ¿ no malfunction.Pre-existing patient conditions, tooth location, implantation period and x-ray images are irrelevant to this investigation.Review of appropriate documentation: document reviewed: instructions for use for biomet 3i kits and instruments (p-zbdinstrp) rev e - 2022/04/01 & biomet 3i dental implant ifu (p-iis086gi) rev j ¿ 2022/08/01.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.Dhr review: dhr review could not be performed as the lot numbers were not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review: a complaint history review by item numbers was conducted for the iipdts dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/ product holds for the reported product for similar events (complaint category keyword: functional: does not disengage/release & wear).Complaint history review could not be performed for the unknown implant since lot/item number was unknown.Post market trending review: october post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information and functional testing, iipdts malfunction did not occur, implant malfunction could not be verified and the reported event (does not disengage) has been unconfirmed.

Event Description

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

• Brand Name: CERTAIN® 4, 5, 6MM(D) IMPLANT DRIVER TIP - SHORT
• Type of Device: DENTAL IMPLANT 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: 15131717
• MDR Text Key: 304185830
• Report Number: 0001038806-2022-01155
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IIPDTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose