MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 15MM; DENTAL IMPLANT

Model Number	BNST415
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
The doctor reported that he placed the cover screw after placing the implant in dental position number #42.Later, he realized that an abutment was necessary so he proceeded to remove the cover screw but it was not possible to separate it from the implant.The doctor removed the implant with the jammed cover screw and placed another implant in the same surgery.The doctor confirmed that the patient did not suffer any impact with his health.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following section has been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One 3i t3® with dcd® non-platform switched tapered implant 4 x 15mm was returned for investigation and evaluated.Visual evaluation of the as returned product identified the implant returned with cover screw attached, signs of use and dried blood and bone.Functional testing recreated the reported event and determined the cover screw could not be disengaged from implant, confirming the stuck event and does not disengage malfunction.Pre-existing conditions (low bone density (type iii) and good oral hygiene) included on the per are unrelated to the reported event.The reported device was placed on tooth 43 (fdi) for a single day and the event occurred during the placement procedure.Device history record (dhr) review was completed for the subject lot number (2020091259).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 (2020091259) for similar events and no other complaint was identified (complaint category keyword(s): does not disengage/release).November post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or device.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed as functional testing recreated the reported event and determined the cover screw could not be disengaged from implant.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).

• Brand Name: 3I T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 15MM
• 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: 12588351
• Report Number: 0001038806-2021-01903
• Device Sequence Number: 19599904
• Product Code: DZE
• UDI-Device Identifier: 00844868029175
• UDI-Public: (01)00844868029175(17)251117(10)2020091259
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2022

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: 11/17/2025
• Device Model Number: BNST415
• Device Catalogue Number: BNST415
• Device Lot Number: 2020091259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• 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: 09/13/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 01/06/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 01/19/2022; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG