MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H); DENTAL ABUTMENT

Model Number	IEHA464
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient called and stated that their healing abutment felt weird.It was discovered on the x-ray that the healing abutment was not seated and was unable to be torqued down further.It was removed and replaced with an angled abutment, which seated and the patient is currently fine.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: investigation type codes were added: 3331, 4109, 4111 and 4114.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.An certain® bellatek® encode® healing abutment 4.1mm(d) x 6mm(p) x 4mm(h) (ieha464) and 3i t3® tapered implant 5/4 x 10mm (bopt5410) were not returned for investigation.Since products have not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.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.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimmer biomet.Dhr review was completed for the subject lot numbers (2020120545 and 1235187).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1235187) for similar events and 1 other relevant complaint was identified.Complaint history review was performed for the reported lot number (2020120545) for similar events and no other complaint was identified.The reported event could not be recreated due to the nature of the dental device and event and the complaint is related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause determined from the investigation is the clinician does not follow the recommended protocol for product placement and final seating and treatment planning and clinician uses excessive torque to place or remove restorative component on implant.No further investigation and no 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 at the time of this report.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(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: 12925819
• Report Number: 0001038806-2021-02295
• Device Sequence Number: 14649525
• Product Code: NHA
• UDI-Device Identifier: 00844868004684
• UDI-Public: (01)00844868004684(17)250108(10)1235187
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 01/08/2025
• Device Model Number: IEHA464
• Device Catalogue Number: IEHA464
• Device Lot Number: 1235187
• 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: 11/10/2021
• Supplement Date Received by Manufacturer: 05/28/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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
• Patient Sex: Unknown