MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	NT3213
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.
Event or Problem Description
It was reported that half screw inserted.Only half of the cover screw was inserted.Reinserted with other implants.There is no health hazard.Distributor confirm another nt3213 was implanted.This implant was never placed in the mouth.The damage to the threads on the outside of the implant is said to have been damaged when the body was pinched with an instrument.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One osseotite® tapered implant 3.25 x 13mm (nt3213) with cover screw, but without packaging was returned for investigation.Visual evaluation of the as returned product, identified damaged external threads most likely from removal process (as mentioned in complaint description, body was pinched with an instrument).Additionally, some damage to the implant internal drive feature, also identified.Functional testing to recreate the reported event could be performed.And cover screw did not assemble with the returned implant.Patient pre-existing conditions, tooth location, placement duration and x-ray image were irrelevant to this investigation.X-ray was not provided, but picture image provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2019061447.It was confirmed, that all operations and inspections were execute,d as per applicable procedure.No deviations or non-conformances, 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 by lot number (2019061447) was performed, for similar event and no complaint about nonconforming products was identified.Therefore, based on the available information, device malfunction did occur.And the reported event was confirmed.

• Brand Name: OSSEOTITE® 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: 12147163
• Report Number: 0001038806-2021-01228
• Device Sequence Number: 4215203
• Product Code: DZE
• UDI-Device Identifier: 00844868011989
• UDI-Public: (01)00844868011989(17)240828(10)2019061447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 08/28/2024
• Device Model Number: NT3213
• Device Catalogue Number: NT3213
• Device Lot Number: 2019061447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• 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: 06/24/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• 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
• Patient Age: 61 YR
• Patient Sex: Male