MAUDE Adverse Event Report: BIOMET 3I T3 PRO TAPERED IMPLANT 6/5MM (D) X 11.5MM (L); DENTAL IMPLANT

Catalog Number	T3PT6511
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported internal hex of implant was stripped during placement.Implant was removed and replaced with another one.Tooth 30.
Additional Manufacturer Narrative
Zimvie complaint number cmp- (b)(4).
Additional Manufacturer Narrative
Zimvie received one (1) t3pt6511, (t3 pro tapered implant 6/5mm (d) x 11.5mm (l)) for evaluation.Visual evaluation was performed, unable to detach "removal tool" to verify claim that the internal hex of implant is damaged.Note, the stuck removal tool did not contribute to the event.The issue occurred during removal of the implant.Tool identified as a ir615.Dhr review was completed for the subject lot number 2023030429.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 2023030429 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per (b)(4), the most likely root cause determined from the investigation was the torque or speed applied during placement/seating exceeded recommended value.However, a definitive root cause could not be identified.Therefore, based on the available information, a device malfunction could not be verified.The implant had a removal tool stuck to the implant.The reported event was 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 available at the time of this report.

• Brand Name: T3 PRO TAPERED IMPLANT 6/5MM (D) X 11.5MM (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: 18323765
• Report Number: 0001038806-2023-02417
• Device Sequence Number: 7316077
• Product Code: DZE
• UDI-Device Identifier: 00844868046820
• UDI-Public: (01)00844868046820(17)280321(10)2023030429
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: T3PT6511
• Device Lot Number: 2023030429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• 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: 12/13/2023
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic