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

Model Number	FNT3211
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that during the surgery placing an implant in tooth location #13, the mount did not disengage from the implant.Doctor took another implant with another mount to finish the procedure.
Additional Manufacturer Narrative
Product evaluation: one full osseotite® tapered implant 3.25 x 11.5mm (fnt3211) and unknown legacy biomet mount were returned for investigation.Visual evaluation of the as returned products identified that the devices were attached to each other.Functional testing was performed but the devices could not disengage.Therefore, the reported event was confirmed.No pre-existing conditions were noted on the per.The reported devices were intended for an unknown tooth location.X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: per the applicable ifu, under the section precautions, it is stated that improper technique may lead to device failure.Dhr review (fnt3211): dhr review for the lot (2018112225) 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 (fnt3211): complaint history review was performed for the reported lot number (2018112225) for similar events (complaint category keywords: does not disengage/release) and no other complaint was identified.Post market trending review: may post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
There is no update to the original complaint description provided.

• 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
• MDR Report Key: 11608479
• Report Number: 0001038806-2021-00556
• Device Sequence Number: 3919679
• 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
• 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): 07/13/2021

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: 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: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1