MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD¿, 5MM(D) X 5MM(L); DENTAL IMPLANT

Model Number	BNES505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that the mount is locked to the implant.The doctor indicates that the procedure was not concluded with the placement of another implant.The affected dental position is #36.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One 3i t3 short external hex parallel walled implant with dcd, 5mm(d) x 5mm(l) (bnes505) and mount were returned for investigation.Visual evaluation of the as returned products identified signs of use.The devices were attached to each other (although the screw was not).Functional testing was conducted.The devices could not disengage from each other.Pre-existing patient conditions, tooth location, x-ray, and implantation duration are not relevant to this investigation.Dhr review for the lot (2021120123) had revealed no deviations nor non-conformance's which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2021120123) for similar events (complaint category keywords: does not disengage) and no other complaint was identified.Therefore, based on the available information and functional testing, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3¿ SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD¿, 5MM(D) X 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16090840
• Report Number: 0001038806-2023-00017
• Device Sequence Number: 2045069
• Product Code: DZE
• UDI-Device Identifier: 00844868033592
• UDI-Public: (01)00844868033592(17)261217(10)2021120123
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150571
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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 Model Number: BNES505
• Device Catalogue Number: BNES505
• Device Lot Number: 2021120123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female