MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	ILPC342U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie dental complaint (b)(4).
Event or Problem Description
It was reported that abutment fractured on the screw portion on 1 piece abutment.No injury to the patient.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: h2: if follow-up, what type; h3: device evaluated by manufacturer; h6: type of investigation; h6: investigation findings; h6: investigation conclusions; h10: additional narratives/data.The product was not returned.Therefore, the reported event could not be verified.Based on the evaluation, device malfunction could not be verified.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, the products were within specifications and conforming when it left zimvie.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be determined.No further investigation and no 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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(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: 14877164
• Report Number: 0001038806-2022-01016
• Device Sequence Number: 14910798
• Product Code: NHA
• UDI-Device Identifier: 00844868021100
• UDI-Public: (01)00844868021100(17)260601(10)2021050578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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 Expiration Date: 06/01/2026
• Device Model Number: ILPC342U
• Device Catalogue Number: ILPC342U
• Device Lot Number: 2021050578
• Was Device Available for Evaluation?: No
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: 70 YR
• Patient Sex: Female