MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® TAPERED IMPLANT 6/5 X 10MM; DENTAL IMPLANT

Model Number	BNPT6510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the hex of the implant was stripped.Removed using implant removal kit, implant removal screw is stuck in implant.Customer reported that the implant did strip during placement, but they do not have any information on which tool was used.They purchased an (irkit) implant removal kit and they believe the m1.6 removal screw may have been stuck in the implant.Confirmed that the implant was placed on (b)(6) 2021, then removed & replaced on (b)(6) 2021 after they received the removal kit.Tooth location # 19.Note: implant removal screw is single use.
Additional Manufacturer Narrative
One 3i t3® with dcd® tapered implant 6/5 x 10mm (bnpt6510) and removal tool were returned for investigation.However, and unknown placement driver was reported but not returned.Visual evaluation of the as returned implant identified signs of use (bone/blood residue around the external threads).Additionally, it was engaged to a removal tool for which there were no allegations.Functional testing was performed to remove the removal tool from the implant drive feature.The devices were determined to be stuck.Damage/malfunction observed on returned implants due to trephine removal is not considered a malfunction or failure of the implant.Zimmer biomet is not responsible for any damage caused by the clinician's removal of the device.As a result, the reported event (damaged drive feature) could not be confirmed/verified as the driver feature was not accessible.No pre-existing conditions were noted on the per.The reported implant had been placed on tooth #19 for approximately 1 week.Picture images were not provided.Appropriate documentation was reviewed.Dhr & complaint history review (unknown placement driver): dhr and complaint history review could not be performed since the lot number associated to the item was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Dhr review (bnpt6510): dhr review for the lot (2019111850) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review (bnpt6510): complaint history review was performed for the reported lot number (2019111850) for similar events and no other complaint was identified.Based on the available information, device malfunction and the reported event could not be verified since the driver was not returned and the implant drive feature was not accessible.The following sections have been updated: h3: changed "yes" to "no" h10: added manufacturer narrative.Device not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3® WITH DCD® TAPERED IMPLANT 6/5 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: 12172472
• Report Number: 0001038806-2021-01274
• Device Sequence Number: 19231481
• Product Code: DZE
• UDI-Device Identifier: 00844868029502
• UDI-Public: (01)00844868029502(17)250108(10)2019111850
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2021
• 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): 11/12/2021

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: Lay User/Patient
• Device Expiration Date: 01/08/2025
• Device Model Number: BNPT6510
• Device Catalogue Number: BNPT6510
• Device Lot Number: 2019111850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• 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: 06/25/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2020
• 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: 78 YR
• Patient Sex: Male