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

Model Number	IEHA466
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported could not get healing abutment to seat.Maybe stripped.Tooth 31.Another product was used to finish the procedure.The site was grafted with allograft prior to original implant placement.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Additional Manufacturer Narrative
This report is being submitted to report additional information.The reported product was returned for investigation.The reported event was non-verifiable.Based on the evaluation, the device malfunction has not occurred.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported events.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 product.Therefore, based on the available information, the product was within specifications and likely conforming when it left zimvie.Dhr review was completed for the subject lot number (1253160).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were 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 for similar events and no other complaint was identified.A definitive root cause could not be identified.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.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 4.1MM(D) X 6MM(P) X 6MM(H)
• Common Device Name: 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: 16370642
• Report Number: 0001038806-2023-00284
• Device Sequence Number: 20447582
• Product Code: DZE
• UDI-Device Identifier: 00844868004691
• UDI-Public: (01)00844868004691(17)270321(10)1253160
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: IEHA466
• Device Catalogue Number: IEHA466
• Device Lot Number: 1253160
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2023
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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
• Patient Sex: Male