MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ 3.4MM(D) DRIVER TIP - LONG; DENTAL DRIVER TIP

Catalog Number IMPDTL

Device Problem Separation Failure (2547)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Event Description

It was reported that driver tip did not disengage from the implant.Procedure has been completed using another device.

Manufacturer Narrative

Zimvie complaint number: (b)(4).Manufacturing date is unknown.

Manufacturer Narrative

Supplemental report provided as the lot number for the device has been provided by the customer and therefore updated.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.D4: expiration date and udi not available, lot number unknown.G3: date received by the manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H4: device manufacture date not available, lot number unknown.H6: evaluation codes.H10: additional narrative.Product evaluation: one implant and one driver tip were returned for investigation.Visual evaluation of the as returned device identified signs of use (bone and blood residue around the external threads of the implant).The two (2) devices were attached to each other and could not be separated.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition was not recorded on the per form.Bone density type is unknown.The reported implant was located on an unknown tooth site and was used for an unknown amount of time.X-ray & picture evaluation: the customer did not provide any images for the reported event.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (biomet 3i dental implant ifu (p-iis086gi) rev j - 1/8/2022.Instructions for use for biomet 3i kits and instruments (p-zbdinstrp), rev e 1/4/2022.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: (impdtl): dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported product are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review: a complaint history review by item number was conducted for the (impdtl) 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.Review completed utilizing keywords: 'functional : does not disengage/release' post market trend review: december post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, a device malfunction did occur and the reported event was confirmed.

Event Description

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

• Brand Name: CERTAIN¿ 3.4MM(D) DRIVER TIP - LONG
• Type of Device: DENTAL DRIVER TIP
• 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: 15553569
• MDR Text Key: 305799898
• Report Number: 0001038806-2022-01527
• 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,Followup
• Report Date: 02/27/2023

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
• Device Catalogue Number: IMPDTL
• Device Lot Number: 1029921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/10/2022; 02/21/2023
• Supplement Dates FDA Received: 10/13/2022; 02/27/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male