MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	NT3211
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant connection was rounded during surgery.Procedure was completed with other implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Patient weight unknown / not provided.Unique identifier (udi) number not available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).One implant was returned for investigation.Visual evaluation of the as returned product identified signs of use, blood and debris around the drive feature.The implant's drive feature was stripped.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was moderate bone density (type ii).The reported device was located on tooth # 36 (fdi) and was used, placed and removed on the same day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08/01.Information identified: contraindications, warnings, precautions and potential adverse events.Per the applicable ifu, it is stated that improper technique and overloading may lead to device failure.Dhr review: dhr review was completed for the subject lot number (2022050967).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2022050967) for similar events and no other complaint was identified.Review completed utilizing keywords: 'damaged drive feature.' post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged drive feature) or product (nt3211).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.

• Brand Name: OSSEOTITE¿ TAPERED IMPLANT 3.25 X 11.5MM
• 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: 16397777
• Report Number: 0001038806-2023-00324
• Device Sequence Number: 20219793
• Product Code: DZE
• UDI-Device Identifier: 00844868011972
• UDI-Public: (01)00844868011972(17)270530(10)2022050967
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Model Number: NT3211
• Device Catalogue Number: NT3211
• Device Lot Number: 2022050967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male