MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 8MM(H); ENCODE HEALING ABUTMENT

Model Number	IEHA578
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant passed the stability test.Encode abutment was placed to ios for restoration.The encode screw became stripped and was unable to be removed from the implant.Implant was removed.Tooth site #2 (universal).
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Event or Problem Description
Tooth site #20 is reported.
Additional Manufacturer Narrative
This report is being submitted to report additional information to 0001038806 - 2022 - 01172.Customer follow up resulted in item number, lot number and tooth number.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The product was returned, and the reported event was confirmed as the returned product was identified as stuck and would not disengage during inspection.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review for the concomitant had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the concomitant for similar events and no other complaint were identified.Dhr review for the reported item had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the reported item for similar events and no other complaint were identified.A definitive root cause could not be determined.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.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® BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 8MM(H)
• Common Device Name: ENCODE HEALING 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: 15148662
• Report Number: 0001038806-2022-01172
• Device Sequence Number: 5553135
• Product Code: NHA
• UDI-Device Identifier: 00844868004868
• UDI-Public: (01)00844868004868(17)260916(10)1248705
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2023

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: Health Professional
• Device Expiration Date: 09/16/2026
• Device Model Number: IEHA578
• Device Catalogue Number: IEHA578
• Device Lot Number: 1248705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 12/30/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/04/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOST610
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female