MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® EX HEX PARALLEL WALLED IMPLANT 4 X 6.5MM; DENTAL IMPLANT

Model Number	BNES465
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).
Event or Problem Description
It was reported that mount could not disengage from implant.Procedure was completed using another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) 3i t3â® with dcdâ® ex hex parallel walled implant 4 x 6.5mm (bnes465) was returned for investigation.Visual evaluation of the as returned product(s) identified that the mount and the implant were engaged.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing to recreate the reported event mount could not disengage from implant verified that the mount and implant engaged and disengaged as intended.A pre-existing condition noted on the per was low bone density (type iii).The reported device was located on unknown tooth location (fdi) and was implanted/explanted on the same day.Device history record (dhr) review was completed for the subject lot number 2017032027.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number 2017032027 for similar events and no other complaint was identified.Review completed utilizing keywords: functional : does not disengage/release.Based on the available information and functional testing, a device malfunction did not occur for the mount and implant.Therefore, the reported event was could not be confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3® WITH DCD® EX HEX PARALLEL WALLED IMPLANT 4 X 6.5MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15204006
• Report Number: 0001038806-2022-01237
• Device Sequence Number: 19383088
• Product Code: DZE
• UDI-Device Identifier: 00844868032847
• UDI-Public: (01)00844868032847(17)220503(10)2017032027
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: Lay User/Patient
• Device Expiration Date: 05/03/2022
• Device Model Number: BNES465
• Device Catalogue Number: BNES465
• Device Lot Number: 2017032027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2017
• 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 Age: 65 YR
• Patient Sex: Male