MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	BOSS410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported that the implant fractured at tooth locations 46 and 44.Patient would have to return to place new implants.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided gender unknown / not provided patient weight unknown / not provided email address unknown / not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) 3i t3 non-platform switched parallel walled implant 4 x 10mm (boss410), one (1) 3i t3 non-platform switched parallel walled implant 4 x 8.5mm (boss485) and one (1) unknown biomet screw were returned for investigation.Visual evaluation of the as returned implants identified fracture at the collar and a fractured screw was identified inside the boss485.Additionally, there was bone residue around the external threads due to usage.Zimvie is not responsible for any damage caused by the clinician's removal of the devices.Functional testing to recreate the reported events could not be performed due to the nature of the devices & events.Pre-existing conditions noted on the per were arterial hypertension and unknown bone density.The reported devices were at tooth location 44 and 46 (fdi) and were used for approximately 2 years, 2 months.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhrs.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers for similar events and no other complaint was identified.Review completed utilizing keywords: fracture implant and fracture screw.Therefore, based on the available information, device malfunction did occur, and the reported events were confirmed.

• Brand Name: 3I T3¿ NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 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: 15608053
• Report Number: 0001038806-2022-01559
• Device Sequence Number: 2327706
• Product Code: DZE
• UDI-Device Identifier: 00844868028819
• UDI-Public: (01)00844868028819(17)240625(10)2019060777
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/25/2024
• Device Model Number: BOSS410
• Device Catalogue Number: BOSS410
• Device Lot Number: 2019060777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2019
• 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: 60 YR
• Patient Sex: Unknown