MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 5/4 X 13MM; DENTAL IMPLANT

Catalog Number	BOPT5413
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant for tooth site #46 disengaged & implant fell to the floor.Another implant was placed in the same procedure.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Additional Manufacturer Narrative
This report is being submitted to report corrected and additional information to 0001038806-2024-01009.The date of event was reported incorrectly and has now been corrected to 4/25/2024.The following sections are being reported: b3: date of event is corrected to 4/25/2024.D4: expiration date and unique identifier (udi) number.D6a: if implanted, give date.D6b: if explanted, give date.D9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: health effect - clinical code.H6: device code(s).H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie received one implant for evaluation.Visual and functional evaluation were performed.The implant had signs of use with debris on its internal threads.The implant engaged and disengaged with an in-house driver as intended.Dhr review was completed for the subject lot number.No deviations or non-conformance's, 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.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was possibly user caused.However, a definitive root cause could not be determined since a device malfunction did not occur.Therefore, based on the available information, a device malfunction did not occur.The implant engaged and disengaged with an in-house driver as intended.The reported event was unconfirmed following functional testing and physical evaluation.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 or corrected information to report.

• Brand Name: 3I T3 TAPERED IMPLANT 5/4 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: 19330211
• Report Number: 0001038806-2024-01009
• Device Sequence Number: 6816193
• Product Code: DZE
• UDI-Device Identifier: 00844868029830
• UDI-Public: (01)00844868029830(17)251216(10)2020111345
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Expiration Date: 12/15/2025
• Device Catalogue Number: BOPT5413
• Device Lot Number: 2020111345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/16/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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: 37 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic