MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H); DENTAL ABUTMENT

Catalog Number	ILPC343U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that the dental abutment located in position number #24 failed because it fractured at the screw part.The doctor reports that the procedure was concluded by using another item.
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.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.Zimvie received one (1) ilpc343u, certain low profile one-piece abutment 3.4mm(d) x 3mm(h) for evaluation.Visual evaluation was performed.The returned abutment has signs of use and was observed fractured at the screw threads.Device history record (dhr) review was completed for the subject lot number 2022080799.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 2022080799 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : abutment based on the investigation and risk management file review, the most likely root cause determined from the investigation was possibly user caused.Therefore, based on the available information, a device malfunction did occur.The returned abutment has signs of use and was observed fractured at the screw threads.The reported 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.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21544953
• Report Number: 0001038806-2025-00476
• Device Sequence Number: 12696726
• Product Code: NHA
• UDI-Device Identifier: 00844868021094
• UDI-Public: (01)00844868021094(17)270908(10)2022080799
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: ILPC343U
• Device Lot Number: 2022080799
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2025
• 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: 03/07/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic