MAUDE Adverse Event Report: BIOMET 3I 3I T3 EX HEX TAPERED IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	BOET485
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that there was a damage in the implant connection.Doctor used another implant with the same mount and he was able to complete the procedure.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One 3i t3® ex hex tapered implant (boet485) and removal tool were returned for investigation.Visual evaluation of the as returned products identified that the removal tool was engaged in the implant.This investigation covered only the implant.Functional testing of the drive feature could not be performed since the tool could not be removed from the implant.Pre-existing conditions, tooth location, x-ray and implantation period are irrelevant to this investigation.Device history record (dhr) review for the lot (2019060194) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.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 lot (2019060194) for similar events and no other complaint was identified.Therefore, based on the available information, the reported malfunction and event could not be verified since the implant drive feature was not accessible as the removal tool was still inside.However, an unrelated malfunction did occur as the tool could not disengage from the implant.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 EX HEX TAPERED IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10498900
• Report Number: 0001038806-2020-01317
• Device Sequence Number: 3123931
• Product Code: DZE
• UDI-Device Identifier: 00844868033295
• UDI-Public: (01)00844868033295(17)240613(10)2019060194(241)BOET485
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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 Expiration Date: 06/13/2024
• Device Model Number: BOET485
• Device Catalogue Number: BOET485
• Device Lot Number: 2019060194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1