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

Catalog Number	BNSS510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
The restorative dentist was unable to seat the abutment at tooth site #19 possibly due to some internal distortion of the implant; therefore, the patient would have to return for implant removal, graft and replacement.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D1: brand name updated.D3: manufacturer email address.D9: device availability.G1: contact office (and manufacturing site for devices) contact name and email.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H10: additional narrative.Zimvie received one (1) bnss510, (3i t3 with dcd non-platform switched 10mm l, 5mm d) for evaluation.Visual evaluation was performed.Implant internal threads damaged.External threads could be seen damaged as well possibly due to removal.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2022010206.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 2022010206 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: damaged threads.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was user error.Therefore, based on the available information, a device malfunction did occur.The implant internal threads were damaged.External threads could be seen damaged as well possibly due to removal.The reported event was confirmed.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.H3 other text : investigation results.

• Brand Name: 3I T3 WITH DCD NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 5 X 10MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18341319
• Report Number: 0001038806-2023-02457
• Device Sequence Number: 17827498
• Product Code: DZE
• UDI-Device Identifier: 00844868029199
• UDI-Public: (01)00844868029199(17)270204(10)2022010206
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BNSS510
• Device Lot Number: 2022010206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic