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

Model Number	FNT3211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
The doctor reports that the cover screw fractured inside the implant and therefore the doctor had to remove the implant.The affected dental position is 31.The patient did not suffer any impact on his health and that the procedure was concluded with another implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.One full osseotite® tapered implant 3.25 x 11.5mm (fnt3211) was returned for investigation.Visual evaluation of the as returned product identified the implant severely damaged, possibly from the removal process.Screw fracture could not be confirmed since, no fractured screw was returned nor could be identified in the drive feature.The cover screw is bundle together with the implant.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 unknown bone density type.The reported device was located on tooth 31 (fdi) and was placed and removed on the same day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019 and biomet 3i dental implant ifu (p-iis086gi) rev h - july 2021.Per the applicable ifu, it is stated that improper technique can lead to device failure.Additionally, breakage may occur when device is loaded beyond its functional capability.Dhr review: dhr review was completed for the subject lot number (2018112225).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, 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: complaint history review was performed for the reported lot number (2018112225) for similar event using keywords fracture screw.And no other complaints were identified.Post market trend review: november post market trending was reviewed and there were no actionable events or corrective actions for the reported event (fracture screw) or product (fnt3211).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.

• Brand Name: FULL 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: 12369409
• Report Number: 0001038806-2021-01606
• Device Sequence Number: 19862415
• Product Code: DZE
• UDI-Device Identifier: 00844868003281
• UDI-Public: (01)00844868003281(17)231213(10)2018112225
• 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: 2021
• Device Explanted Year: 2021
• 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): 01/26/2022

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: 12/13/2023
• Device Model Number: FNT3211
• Device Catalogue Number: FNT3211
• Device Lot Number: 2018112225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• 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: 08/04/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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: Unknown