MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ BELLATEK¿ ENCODE¿ HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H); DENTAL ABUTMENT

Model Number	IEHA353
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported dentist call to let us know that he was unable to removed encode healing abutment.When patient arrived to the office, encode cap was strip and implant needed to be removed.Tooth 8.Surgical/medical intervention required for permanent damage: no.Was there a delay during the procedure: no.Additional appointment required: yes, uncovering of new implant.Was the procedure completed using another implant or another device: yes, same brand implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) ieha353, (certain bellatek encode healing abutment 3.4mm(d) x 5mm(p) x 3mm(h)) and one (1) xiitp4313 (osseotite tapered certain prevail implant 4/3 x 13mm) for evaluation.Visual evaluation was performed, there was signs of use.There was debris on the implants external threads.The abutment was attached to the implant and could not be removed.The abutments drive feature was damaged along with the abutment itself.This complaint refers to the ieha353.Dhr review was completed for the subject lot number 1240846.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 1240846 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was missing or confusing instructions for use and torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The abutments drive feature was damaged and could not be disengaged from the implant.The reported event was confirmed.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¿ BELLATEK¿ ENCODE¿ HEALING ABUTMENT 3.4MM(D) X 5MM(P) 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17133105
• Report Number: 0001038806-2023-01157
• Device Sequence Number: 7377645
• Product Code: NHA
• UDI-Device Identifier: 00844868004554
• UDI-Public: (01)00844868004554(17)251112(10)1240846
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/12/2025
• Device Model Number: IEHA353
• Device Catalogue Number: IEHA353
• Device Lot Number: 1240846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic