MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	BNSS410
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported dental office only order tapered abutments but noticed during a procedure that the implant was a bnss410 and not a bost410.Dr was able to complete the procedure using the correct implant they intended to.The label and everything stated it was a bnss410 they just didn't realize prior to the procedure that it was not the one they intended to use and always order.Implant was never placed in patient's mouth.Tooth location not reported.
Additional Manufacturer Narrative
One (1) 3i t3® with dcd® non-platform switched parallel walled implant 4 x 10mm (bnss410) was returned for investigation.Visual evaluation of the as returned product identified the implant was returned outside of its original packaging (no malfunction).Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing patient factors, tooth location, and x-rays are not relevant to the reported event.The device was reported and noticed during a procedure.The customer did not provide any pictures.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2020060293).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 (2020060293) for similar event and no other complaint was identified.Based on the available information, packaging malfunction could not be verified and the reported event was non-verifiable.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Based on further complaint review and reassessment of the reported event, it was determined, that mfr report number 0001038806-2021-01075 and 0001038806-2021-01075-1 were reported in error.Please disregard these submissions.No further reports will be submitted for this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM
• 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: 12032227
• Report Number: 0001038806-2021-01075
• Device Sequence Number: 4987874
• Product Code: DZE
• UDI-Device Identifier: 00844868029038
• UDI-Public: (01)00844868029038(17)250804(10)2020060293
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2021

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: 08/04/2025
• Device Model Number: BNSS410
• Device Catalogue Number: BNSS410
• Device Lot Number: 2020060293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• 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: 06/11/2021
• Supplement Date Received by Manufacturer: 10/28/2021; 10/28/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 11/07/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• 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 Sex: Prefer Not To Disclose