MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ EX HEX TAPERED IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Catalog Number	BNET3210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that the implant fractured along the body and that the missing part was swallowed by the patient and later evacuated, so it will not be returned.Nothing remains implanted in the patient's mouth.Bone type iii and affected dental position = 16.The procedure was not completed but had no impact on the patient's health.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) fragment of the bnet3210, (3i t3 with dcd ex hex tapered implant 3.25 x 10mm) for evaluation.Visual evaluation of the as returned device identified only half of the implant with signs of use.The implant was identified fractured at the body.The remaining half of the fractured implant was not returned for evaluation.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr) review was completed for the subject lot number 2019121251.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2019121251 for similar events and no other complaint was identified.Review completed utilizing keywords: fracture implant & ingestion/swallowing based on the investigation and risk management file review, the most likely root causes determined from the investigation are parafunctional habits/patient factors, or customer error.Therefore, based on the available information, a device malfunction did occur.The reported event (fracture implant) was confirmed with all the available information.The ingestion/swallowing event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.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 is available at the time of this report.

• Brand Name: 3I T3¿ WITH DCD¿ EX HEX 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20004744
• Report Number: 0001038806-2024-01875
• Device Sequence Number: 17381743
• Product Code: DZE
• UDI-Device Identifier: 00844868033004
• UDI-Public: (01)00844868033004(17)250120(10)2019121251
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133049
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 01/19/2025
• Device Catalogue Number: BNET3210
• Device Lot Number: 2019121251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• 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: 08/20/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic