MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD¿, 5MM(D) X 6MM(L); DENTAL IMPLANT

Catalog Number	BNES506
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: patient weight unknown / not provided.D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that the mount is locked inside the implant despite completely removing the screw.The affected tooth position is #36.The doctor reports in the per that the procedure was concluded by placing another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) bnes506, (3i t3 short external hex parallel walled implant with dcd, 5mm(d) x 6mm(l)) for evaluation.Visual evaluation / functional test was performed, there was bone debris on the implant¿s external threads.The implants mount wouldn¿t disengage from the implant.Device history record (dhr) review was completed for the subject lot number 2021060874.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 2021060874 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release based on the investigation and risk management file review, the most likely root cause determined from the investigation was the torque applied during placement/seating exceeded recommended value.Therefore, based on the available information, a device malfunction did occur.The mount wouldn¿t disengage from the implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3¿ SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD¿, 5MM(D) X 6MM(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 ; 5619713230
• MDR Report Key: 17354873
• Report Number: 0001038806-2023-01356
• Device Sequence Number: 20121877
• Product Code: DZE
• UDI-Device Identifier: 00844868033608
• UDI-Public: (01)00844868033608(17)260713(10)2021060874
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150571
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/28/2024

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: Lay User/Patient
• Device Expiration Date: 07/12/2026
• Device Catalogue Number: BNES506
• Device Lot Number: 2021060874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• 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: 07/19/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic