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	Misconnection (1399)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that the implant hex was damaged and when holding it with the driver, implant fell to the ground.Another implant was placed during the same surgery.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).A 3i t3® with dcd® non-platform switched tapered implant 4 x 15mm (bnst415) was returned for investigation.Visual evaluation of the as returned product identified no damage.The investigation has been performed based on the available information.Functional testing was performed for the returned product with an in-house stock device and functioned as intended.No malfunction.Pre-existing condition noted on the per is bruxism however does not contribute to the complaint.The reported device tooth location and length of usage is unknown.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (2015051623).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.Complaint history review was performed for the reported lot number (2015051623) for similar event and no other complaint was identified.June 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 not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information is available at the time of this report.

• 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
• MDR Report Key: 10137164
• Report Number: 0001038806-2020-00815
• Device Sequence Number: 2241236
• Product Code: DZE
• UDI-Device Identifier: 00844868029175
• UDI-Public: (01)00844868029175(17)200604(10)2015051623(241)BNST415
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 06/04/2020
• Device Model Number: BNST415
• Device Catalogue Number: BNST415
• Device Lot Number: 2015051623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1