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

Catalog Number	BOSS410
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It is reported that the implant case came without an implant inside.No other complications reported.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) boss410, (3i t3 non-platform switched parallel walled implant 4 x 10mm) for evaluation.Visual evaluation of the as returned device identified only the sterile inner vial already opened, without it's original packaging / box.Additionally, the sterile inner vial was returned inside an autoclave bag / pouch, the sterile inner vial was missing the implant; however, the cover screw was seen inside.Therefore, the coob is non-verifiable as the conditions of the packaging / product when delivered to the customer are unknown / non-verifiable.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 2023020456.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 2023020456 for similar events and no other complaint was identified.Review completed utilizing keywords: incorrect component quantity.The customer did submit two (2) images for the reported event.The images did not provide additional evidence.Based on the investigation and risk management file, the most likely root cause determined from the investigation is improper handling of devices/packaging outside of zimvie control.Therefore, based on the available information, a packaging malfunction could not be verified.The reported event/coob was non-verifiable since the condition of the product/packaging received by the customer was unknown / non-verifiable.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.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¿ 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20003850
• Report Number: 0001038806-2024-01871
• Device Sequence Number: 14681249
• Product Code: DZE
• UDI-Device Identifier: 00844868028819
• UDI-Public: (01)00844868028819(17)280221(10)2023020456
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2025

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: Health Professional
• Device Catalogue Number: BOSS410
• Device Lot Number: 2023020456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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 Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic