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

Model Number	BOES505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stuck mount.The implant mount did not come off.The doctor was able to respond by exchanging the same product number and lot number.In particular, there is no difference in technique from usual.No health hazard.The procedure was completed using another implant or another device.Tooth site # 18.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie received one (1) boes505, (3i t3® short external hex parallel walled implant, 5mm(d) x 5mm(l)) for evaluation.Visual evaluation of the as returned product identified the implant and mount with signs of use, wear.The mount has markings around the hex region suggesting it was over torqued.During a functional test the mount does not separate from the implant.The coob is non-verifiable as the implant and mount have signs of being used and the product was returned outside of its original packaging, the condition of the product when delivered to the customer is unknown / non-verifiable.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2021120124.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 2021120124 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿does not disengage/release.¿ the customer did not submit images for the reported event.Ifu review: documents reviewed: biomet 3i dental implant ifu p-iis086gi rev.J 2022/08.Information identified: "warnings" & "contraindications" based on the investigation and risk management file review as per rmf rm-00053-haz rev.11, the most likely root causes determined from the investigation are missing or confusing instructions for use, torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, and functional testing a device malfunction did occur.The reported coob was non-verifiable since the condition of the product/packaging when received by the customer was unknown / non-verifiable.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(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: 16875884
• Report Number: 0001038806-2023-00860
• Device Sequence Number: 12220074
• Product Code: DZE
• UDI-Device Identifier: 00844868033639
• UDI-Public: (01)00844868033639(17)270107(10)2021120124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2023

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 Model Number: BOES505
• Device Catalogue Number: BOES505
• Device Lot Number: 2021120124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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: 61 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic