MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ EP¿ HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H); DENTAL IMPLANT

Model Number	IMHA34
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the abutment became loose and doctor tightened and sent patient home.Abutment was discarded.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
One (1) certain ep healing abutment 3.4mm(d) x 3.8mm(p) x 4mm(h) (imha34) was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing condition noted, and no per form was provided.Bone density type is unknown.The reported device was located on an unknown tooth site (universal) and was used for an unknown amount of time.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1241643).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, 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 (1241643) for similar events and no other complaint was identified.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event (loosening) or product (imha34).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction and the reported event could not be verified.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN¿ EP¿ HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)
• Common Device Name: DENTAL IMPLANT
• 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: 15954788
• Report Number: 0001038806-2022-01879
• Device Sequence Number: 7426751
• Product Code: NHA
• UDI-Device Identifier: 00844868006275
• UDI-Public: (01)00844868006275(17)251220(10)1241643
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/23/2023

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: Lay User/Patient
• Device Expiration Date: 12/20/2025
• Device Model Number: IMHA34
• Device Catalogue Number: IMHA34
• Device Lot Number: 1241643
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2020
• 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