MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOCATOR® ABUTMENT 3.4MM(D) X 4MM(H); DENTAL ABUTMENT

Model Number	IMLOA004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
The doctor reports that during the revision of the prosthesis he noticed the fracture of the abutment and proceeded to change it for a new abutment immediately in the same surgery without any type of negative impact on the patient's health.The affected tooth position is #33 the abutment has fractured on the part of the screw.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
The doctor reports that during the revision of the prosthesis he noticed the fracture of the abutment and proceeded to change it for a new abutment immediately in the same surgery without any type of negative impact on the patient's health.The affected tooth position is #33 the abutment has fractured on the part of the screw.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The complaint report was received, reviewed, and evaluated by the manufacturer's complaint process.Applicable manufacturer¿s internal lot history records were reviewed to evaluate whether any internal deviations, non-conformances, or problems occurred during the manufacture of the lot, which could cause or contribute to the reported complaint condition.A review of other manufacturers complaint files and related trending data for similar incidents was performed to evaluate whether other similar complaints have been received and if data suggests any adverse trends may have contributed to the complaint root cause.Condition of the returned complaint related product was evaluated to confirm the reported product complaint.As part of each complaint investigation, the manufacturer performs an analysis to determine the root-cause of the reported problem.Depending upon the information provided, a true root-cause may or may not be determined.In these cases, the most-likely cause of the reported issue would be determined.Other known issues that are inherent to the business operations, typically ones that are related to shipping, handling, customer service, or other, are internally tracked and continually trended for unusual increases.As a result of the above investigation, the manufacturer has concluded the following as the root-cause or most likely root-cause of the reported complaint condition: no manufacturing event was confirmed, event is tracked and trended with no further actions taken at this time.Most likely hazard experience: thread fracture during placement most likely root cause of the failure mode / hazard: thread fracture during placement typically results from application of excessive torque to the abutment.It appears as an elongation of the thinnest section of thread or thread relief.Additional evidence can be damage to the driving feature.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN® LOCATOR® ABUTMENT 3.4MM(D) X 4MM(H)
• 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: 13584634
• Report Number: 0001038806-2022-00255
• Device Sequence Number: 4369102
• Product Code: DZE
• UDI-Device Identifier: 00844868006343
• UDI-Public: (01)00844868006343(17)261005(10)1248551
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K012911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/23/2022

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: Lay User/Patient
• Device Expiration Date: 10/05/2026
• Device Model Number: IMLOA004
• Device Catalogue Number: IMLOA004
• Device Lot Number: 1248551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Female