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

Catalog Number	BOES506
Medical Device Problem Codes	Mechanical Problem (1384); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Gender unknown / not provided.Patient weight unknown / not provided.Additional device information unknown / not provided.Device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that during implant placement it was impossible to separate the mount and the implant was removed.Tooth location (b)(6).Procedure completed with other implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Investigation summary it was reported that during implant placement it was impossible to separate the mount and the implant was removed.Tooth location 46.Procedure completed with different implant.Zimvie received one (1) boes506, (3i t3 short external hex parallel walled implant, 5mm(d) x 6mm(l)) for evaluation.A visual evaluation was performed, the implant, mount, and cover screw were received disengaged.A functional test was performed, and the implant and mount engaged and disengaged as intended.Dhr review was completed for the subject lot number 2022010157.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 2022010157 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : does not disengage/release¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz, the most likely root cause determined from the investigation was missing or confusing instructions for use or the torque applied during placement/seating exceeded recommended value.Therefore, based on the available information, a device malfunction did not occur.The implant and mount engaged and disengaged as intended.The reported event was not 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, 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 ; 5617766700
• MDR Report Key: 16683873
• Report Number: 0001038806-2023-00665
• Device Sequence Number: 12750136
• Product Code: DZE
• UDI-Device Identifier: 00844868033646
• UDI-Public: (01)00844868033646(17)270201(10)2022010157
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150571
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: Other
• Device Catalogue Number: BOES506
• Device Lot Number: 2022010157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic