MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H); DENTAL SCREW

Catalog Number	ILPC441U
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The abutments have unscrewed and were removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Upon review/inspection of returned product.The abutments screw was fractured.Upon follow up on december 12, 2024.Called clinician he is unable to confirm the fracture, he believes that it maybe happened upon removal.Zimvie received one (1) ilpc441u, (certain low profile one-piece abutment 4.1mm(d) x 1mm(h) for evaluation.Visual evaluation was performed, the abutments had signs of use.The abutments screw was fractured at the threads.Threaded piece was not returned.Dhr review was completed for the subject lot number 2023020703.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 2023020703 for similar events and 1 other relevant complaint(s) were identified.Review completed utilizing keywords: dental : functional : loosening.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error.Therefore, based on the available information, a device malfunction did occur.The screw was fractured.The reported loosening event was non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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.

• Brand Name: CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20695356
• Report Number: 0001038806-2024-02652
• Device Sequence Number: 19761664
• Product Code: NHA
• UDI-Device Identifier: 00844868021070
• UDI-Public: (01)00844868021070(17)280301(10)2023020703
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092341
• 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): 01/06/2025

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 Catalogue Number: ILPC441U
• Device Lot Number: 2023020703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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: Female
• Patient Ethnicity: Non Hispanic