MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	BNET3213
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the dental implant located in an unknown position failed because it fractured on the hexagon part, the doctor indicates in the per that the procedure was not concluded with the placement of another implant.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One 3i t3 with dcd non-platform switched tapered implant 3.25 x 13mm ((b)(6)) (with associated mount) was returned for investigation.Visual evaluation of the as returned implant identified signs of use, damage likely from the removal process.Zimvie is not responsible for any damage caused by the clinician's removal of the device.The implant was fractured around the collar.No allegations or malfunction was noticed with the returned mount ((b)(6)).Functional testing could not be performed since the product was fractured.Pre-existing condition noted on the per was ¿unknown bone density".The reported device had been placed on tooth #unk.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot number (2019031891) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Products was conforming at the time it left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019031891) for similar events and no other complaint was identified.Mar post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, 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 3.25 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: 16383575
• Report Number: 0001038806-2023-00305
• Device Sequence Number: 5114469
• Product Code: DZE
• UDI-Device Identifier: 00844868033028
• UDI-Public: (01)00844868033028(17)240410(10)2019031891
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/10/2024
• Device Model Number: BNET3213
• Device Catalogue Number: BNST3213
• Device Lot Number: 2019031891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 60 KG