MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	BNST510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).(b)(6).
Event or Problem Description
It was reported that the internal implant thread at tooth site #36 was not engaging.The specialist was able to remove the crown with some struggle and the healing abutment was placed but would not engage with the implant.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date was updated.D10: unknown healing abutment d10: iwth56, certain® ep® healing abutment 5mm(d) x 5.6mm(p) x 6mm(h), lot# unknown g3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: component code was added: 4755.H6: tyoe of investigation codes were added: 4109, 4111, 4110 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4310 and 4315.H10: narrative/data was updated.The implant was returned (no malfunction).Hence, the reported event was non-verifiable.Based on the evaluation, device malfunction has not occurred for implant.There is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device 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 (2019031866).It was confirmed that all operations and inspections were executed 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 (b)(4): complaint history review was performed for the reported lot number (2019031866) for similar event (keyword category: damaged threads & device malfunction) and no other complaint was identified.Functional testing was performed for implant with in-house abutment/screw, no malfunction identified.A definitive root cause could not be identified.However, based on the investigation, risk review and ifu, the most likely cause determined from the investigation are due to the clinician not following the recommended protocol for product placement and final seating, torque applied during placement/seating exceeds recommended value and clinician inadvertently selects an instrument with the wrong drive feature to place/seat the implant.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.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: 3I T3 WITH DCD NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11693328
• Report Number: 0001038806-2021-00646
• Device Sequence Number: 3535314
• Product Code: DZE
• UDI-Device Identifier: 00844868029298
• UDI-Public: (01)00844868029298(17)240409(10)2019031866
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2024
• Device Model Number: BNST510
• Device Catalogue Number: BNST510
• Device Lot Number: 2019031866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENTS- SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR