MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOCATOR® ABUTMENT 3.4MM(D) X 5MM(H); DENTAL SCREW

Model Number	IMLOA005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Age at time of the event: unknown / not provided.Patient weight: unknown / not provided.Additional device information: unknown / not provided.Device manufacturer date: unknown / not provided.
Event or Problem Description
The doctor reports that the patient goes to his medical office with the prosthesis removed and there the doctor shows the locator breakage in the part of the body.The affected tooth position is #36.The dental procedure was not completed with another item.The patient did not suffer any type of negative impact on his health as a consequence of the event.
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 defect was found.Most likely hazard experience: thread fracture during function.Most likely root cause of the failure mode / hazard: it typically results from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.
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 5MM(H)
• Common Device Name: DENTAL SCREW
• 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: 15392860
• Report Number: 0001038806-2022-01404
• Device Sequence Number: 6179285
• Product Code: DZE
• UDI-Device Identifier: 00844868006350
• UDI-Public: (01)00844868006350(17)251120(10)1241563
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 11/20/2025
• Device Model Number: IMLOA005
• Device Catalogue Number: IMLOA005
• Device Lot Number: 1241563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2020
• 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 Sex: Male