MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW; DENTAL ABUTMENT

Catalog Number	IMUCC2T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that the two screws have fractured through/by the body.The affected dental positions are #43 and #46.The doctor indicates in the per that the procedure was concluded with the placement of another implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Additional device information unknown / not provided.Premarket identification unknown / not provided.Device manufacturer date unknown / not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received two (2) imucc2t, (certain ucla castable non-hexed abutment 3.4mm(d) w/large dia.Ti screw) for evaluation.Visual evaluation of the as returned product identified signs of use, both screws were fractured at the threads.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 1212548.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 1212548 for similar events and no other complaint was identified.Review completed utilizing keywords: fracture screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is attributed to patient factors due to parafunctional habits (bruxism) over the implantation period.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.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 is available at the time of this report.

• Brand Name: CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW
• Common Device Name: DENTAL ABUTMENT
• 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: 16553231
• Report Number: 0001038806-2023-00520
• Device Sequence Number: 5326363
• Product Code: NHA
• UDI-Device Identifier: 00844868006558
• UDI-Public: (01)00844868006558(17)230131(10)1212548
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/02/2023

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: 01/30/2023
• Device Catalogue Number: IMUCC2T
• Device Lot Number: 1212548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• 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: 56 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic