MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H); DENTAL ABUTMENT

Catalog Number	ILPC341U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented with a loose hybrid and when removing the hybrid, two (2) abutments had been found to be fractured.Both abutments had to be replaced.Symptoms as a result of the event: patient had discomfort from prosthesis moving.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided d10: lpcgsh, low profile abutment gold-tite retaining screw/lot# 1254824.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received the reported abutment for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use, and was observed fractured around the collar.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 2023060298.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 2023060298 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are patient factors (patient conditions) or customer error.Therefore, based on the available information, device malfunction did occur.The reported event was confirmed with all the available information.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(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: 19360476
• Report Number: 0001038806-2024-01051
• Device Sequence Number: 20418699
• Product Code: NHA
• UDI-Device Identifier: 00844868021117
• UDI-Public: (01)00844868021117(17)280616(10)2023060298
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: Health Professional
• Device Catalogue Number: ILPC341U
• Device Lot Number: 2023060298
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2024
• 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: 05/21/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL SCREW-SEE H10 NARRATIVE.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic