MAUDE Adverse Event Report: BIOMET 3I 3I T3 NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	BOSS411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
Customer reported upon placement of implant, buccal fracture occurred and osteotomy failed.Tooth 27.Additional appointment required: yes, placed graft delayed placement.Was the procedure completed using another implant or another device: yes, replaced (b)(6) 2020.
Additional Manufacturer Narrative
Zimvie received one (1) boss411, (3i t3 non-platform switched parallel walled implant 4 x 11.5mm) for evaluation.Visual evaluation was performed, slight wear from usage.No damage identified or signs of malfunction.Measurements match drawing.Cal6861 due: (b)(6) may 2024 dhr review was completed for the subject lot number 2019061941.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 was performed for the reported lot number 2019061941 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : bone fracture.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz, the most likely root cause determined from the investigation were missing or confusing instructions for use and inadequate treatment planning.Refer to attached summary investigation for lack of primary stability.Therefore, based on the available information, a device malfunction did not occur.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Similar complaints for the inability to achieve primary stability (unable to place implant into osteotomy) have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.While non-conformances were identified for some lots during manufacturing records reviews, the documented disposition actions for each have not suggested the likely release of non-conforming product.To date, all complaint data was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue caused or contributed to the reported event.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3 NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18088604
• Report Number: 0001038806-2023-02120
• Device Sequence Number: 6753795
• Product Code: DZE
• UDI-Device Identifier: 00844868028826
• UDI-Public: (01)00844868028826(17)240712(10)2019061941
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2024

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: Health Professional
• Device Expiration Date: 07/11/2024
• Device Catalogue Number: BOSS411
• Device Lot Number: 2019061941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic