MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 13MM; DENTAL IMPLANT

Catalog Number	BNST413
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that the implant was not held by the driver because the implant was defective.The procedure was completed with the placement of another implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number cmp-(b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative zimvie received one (1) bnst413, (3i t3 with dcd non-platform switched tapered implant 4.0 x 8.5 - 15.0 mm) for evaluation.Visual evaluation was performed.Some damage to the implant's drive feature can be observed, however, it was tested with in-house driver and it engages as intended.Device history record (dhr) review was completed for the subject lot number 2022110481.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 2022110481 for similar events and one other complaint was identified.Review completed utilizing keywords: dental : functional : damaged drive feature.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was possibly user caused.Therefore, based on the available information, a device malfunction did occur.Damage to the implant¿s drive feature can be observed.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.

• Brand Name: 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 4 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20224388
• Report Number: 0001038806-2024-02052
• Device Sequence Number: 7240085
• Product Code: DZE
• UDI-Device Identifier: 00844868029168
• UDI-Public: (01)00844868029168(17)271122(10)2022110481
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2024

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 Catalogue Number: BNST413
• Device Lot Number: 2022110481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• 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: 09/16/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic