MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ EX HEX TAPERED IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	BOET411
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that once the implant is placed in position #44, he is unable to remove the implant holder / mount from implant.The doctor reports in the per form that the procedure was concluded by placing another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp: (b)(4).D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) boet411, (3i t3 ex hex tapered implant 4 x 11.5mm) for evaluation.Visual evaluation / functional test was performed, mount found to be stuck with slight damaged to the mount screw.Unable to disengage.Dhr review was completed for the subject lot number 2021030852.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 2021030852 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 were missing or confusing instructions for use and torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The summary of the inspection results.The reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3¿ EX HEX TAPERED IMPLANT 4 X 11.5MM
• 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: 16743363
• Report Number: 0001038806-2023-00727
• Device Sequence Number: 6726912
• Product Code: DZE
• UDI-Device Identifier: 00844868033264
• UDI-Public: (01)00844868033264(17)260331(10)2021030852
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• 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): 09/13/2023

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 Expiration Date: 03/30/2026
• Device Catalogue Number: BOET411
• Device Lot Number: 2021030852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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: 54 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic