MAUDE Adverse Event Report: BIOMET 3I 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 5MM(D) X 5MM(L); DENTAL IMPLANT

Model Number	BNES505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant dropped due to not disengaged from tool.After attempt to disengage, the implant fell off, and lost sterility so another implant was placed.Tooth number 30 (universal).
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Additional Manufacturer Narrative
This report is being submitted to report additional information.The device was returned.The reported event was non-verifiable, since the original driver used was not returned.Based on the evaluation and functional testing, device malfunction has not occurred.There is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Functional test with an in-house mating component/driver revealed; the device engage and disengage as normal.The complaint is related to the functional performance of the device.A definitive root cause could not be determined.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 5MM(D) X 5MM(L)
• 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: 12931336
• Report Number: 0001038806-2021-02297
• Device Sequence Number: 3947899
• Product Code: DZE
• UDI-Device Identifier: 00844868033592
• UDI-Public: (01)00844868033592(17)220927(10)2017090853
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K150571
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 09/27/2022
• Device Model Number: BNES505
• Device Catalogue Number: BNES505
• Device Lot Number: 2017090853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• 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: 11/15/2021
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 12/05/2021
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2017
• 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: 65 YR
• Patient Sex: Female