MAUDE Adverse Event Report: BIOMET 3I 3I T3® EX HEX TAPERED IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	BOET485
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the patient came with a fallen prosthesis and a broken prosthesis holding screw, the implant is also fractured.Implant removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.D9: device available for evaluation change ¿no' to 'yes'.G3: date received by the manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.An implant and unknown biomet screw were returned for investigation.Visual inspection of the as returned products identified worn markings due to usage, excessive bone/debris and a fracture on the threads on both implant and screw (screw inside implant).No pre-existing conditions were noted on the per.The reported device was located on tooth #26 and was used for approximately 1 year.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev h - july 2021 information identified: 'warnings' 'precautions' 'potential adverse events'.Documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f ¿ october 2019 information identified: 'warnings' 'precautions' 'potential adverse events'.Dhr review: dhr review was completed for the subject lot number (2011080851).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Dhr review could not be performed, as the lot number associated with the reported unknown biomet screw product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review: complaint history review was performed for the reported lot number (2011080851) for similar event and no other complaint was identified.No complaint history review could be performed without relevant lot and item information unknown biomet screw.Review completed utilizing keywords: fracture : implant and fracture : screw.Post market trend review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: 3I T3® EX HEX TAPERED IMPLANT 4 X 8.5MM
• 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: 13257037
• Report Number: 0001038806-2022-00047
• Device Sequence Number: 19218977
• Product Code: DZE
• UDI-Device Identifier: 00844868033295
• UDI-Public: (01)00844868033295(17)240613(10)2019060194
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/13/2024
• Device Model Number: BOET485
• Device Catalogue Number: BOET485
• Device Lot Number: 2019060194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 96 KG