MAUDE Adverse Event Report: BIOMET 3I 3I T3® TAPERED IMPLANT 6/5 X 11.5MM; DENTAL IMPLANT

Model Number	BOPT6511
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem 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.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One (1) 3i t3® tapered implant 6/5 x 11.5mm (bopt6511) 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.Dhr review: bopt6511.Dhr review was completed for the subject lot number (2021041326).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Complaint history review: bopt6511 complaint history review was completed for the subject lot number (2021041326) using keyword damaged drive feature and no other complaint was identified.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 (bopt6511).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.Sections updated b4: date of this report g3: date investigation results were received g6: type of report and follow up number h2: follow up type h3: device evaluated h6: adverse event problem codes h10: manufacturer's narrative.

• Brand Name: 3I T3® TAPERED IMPLANT 6/5 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• 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: 12982834
• Report Number: 0001038806-2021-02347
• Device Sequence Number: 5274289
• Product Code: DZE
• UDI-Device Identifier: 00844868029861
• UDI-Public: (01)00844868029861(17)260517(10)2021041326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2026
• Device Model Number: BOPT6511
• Device Catalogue Number: BOPT6511
• Device Lot Number: 2021041326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female