MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Model Number	BNST3210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that implant fractured.Patient received 1 stage implant placement procedure and final attachment restoration.After 2 years of functioning , the implant was suddenly fracture in two pieces., so we had to remove the implant.Tooth site # 15.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One (1) 3i t3 with dcd non-platform switched tapered implant 3.25 x 10mm (bnst3210) was returned for investigation.Visual evaluation of the as returned implant identified fracture at the threads, signs use, and external damage possibly from the removal process.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Additionally, an unknown zest locator was returned.However, no information was given about this product and no malfunction was identified, so it has been added as an associate item.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing conditions noted on the per were smoker, inadequate oral hygiene, and low bone density (type iii).The reported device was in tooth location 15 (fdi) and was used for approximately 1 year, 10 months.The customer did provide x-ray or pictures.Appropriate documents were reviewed.Dhr review was completed for the subject lot number 2018040668.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.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.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed as physical evaluation identified the fractured implant.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 10MM
• 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: 15577289
• Report Number: 0001038806-2022-01537
• Device Sequence Number: 7384788
• Product Code: DZE
• UDI-Device Identifier: 00844868029090
• UDI-Public: (01)00844868029090(17)230426(10)2018040668
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/26/2023
• Device Model Number: BNST3210
• Device Catalogue Number: BNST3210
• Device Lot Number: 2018040668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male