MAUDE Adverse Event Report: BIOMET 3I T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 10MM (L); DENTAL IMPLANT

Catalog Number	T3ST3210
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the driver did not fit.The placement driver impdtl did not fit properly in the t3st3210 and was removed.It was replaced with another similar product.This driver impdtl fitted without any problems in another t3st3210, so the doctor is requesting an investigation into the defect in the current t3st3210.No symptoms as a result of the event.No surgical/medical intervention required for permanent damage.No additional appointment required.Doctor completed the procedure with another similar product.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).
Additional Manufacturer Narrative
Zimvie received one (1) t3st3210, (t3® pro non-platform switched tapered implant 3.25mm (d) x 10mm (l)) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent minor debris attached to external threads.The implant was identified as reported and the implant's drive feature was observed worn out a bit; however, an in-house impdts driver was used during a functional test, and the driver engaged, retained, and disengaged the implant as intended.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2120004889.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 2120004889 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fit other¿ the customer did submit one (1) image of the subject implant for the reported event (see attachments tab at ce level.) based on the investigation and risk management file review as per rmf rm-00053-haz rev.12, the most likely root cause determined from the investigation is incorrect techniques used - customer error.Therefore, based on the available information, and functional testing the implant malfunction did not occur.The reported event was non-verifiable with all the available information, and without return of all devices involved.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.The following sections have been updated: b4: date of this report d4: device expiration date d4: device udi number d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h4: device manufacture date h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 10MM (L)
• 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: 20932578
• Report Number: 0001038806-2024-02922
• Device Sequence Number: 15545378
• Product Code: DZE
• UDI-Device Identifier: 00844868046868
• UDI-Public: (01)00844868046868(17)281021(10)2120004889
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: T3ST3210
• Device Lot Number: 2120004889
• 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: 12/14/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2023
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic