MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	BNST413
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4). .
Event or Problem Description
It was reported that implant uncovered w/encode placement flush.On removal and retuned to omfs encode abut (old and new) did not seat flush.Encode did not seat w/implant.Implant was removed.Procedure was completed using another implant.Tooth # 9.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
A 3i t3â® with dcdâ® non-platform switched tapered implant 4 x 13mm (bnst413) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage.Damage identified outside and inside of implant.Two unknown encode abutment were not returned.Since products have not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Functional testing was performed for the returned product implant with an in-house stock cover screw and it can not fully seat into implant.Malfunction identified.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Pictures images were not provided.Appropriate documentation was reported.Dhr review was completed for the subject lot number (2020110189).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Dhr review could not be performed, as the lot number associated with the reported products are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review was performed for the reported lot number (2020110189) for similar event and no other complaint was identified.No complaint history review could be performed without relevant lot and item information for unknown encode abutment.July post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did occur and the reported event was confirmed.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: 3I T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 13MM
• 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: 13905381
• Report Number: 0001038806-2022-00436
• Device Sequence Number: 14528869
• Product Code: DZE
• UDI-Device Identifier: 00844868029168
• UDI-Public: (01)00844868029168(17)251211(10)2020110189
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: 12/11/2025
• Device Model Number: BNST413
• Device Catalogue Number: BNST413
• Device Lot Number: 2020110189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male