MAUDE Adverse Event Report: BIOMET 3I 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 5MM(D) X 5MM(L); DENTAL IMPLANT

Model Number	BNES505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that after placing the implant it was not possible to remove the mount.The doctor confirmed that the dental surgical procedure was completed with another implant on the same day without any negative impact on the patient.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information g3: date received by manufacturer g6: type of report h1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative one (1) 3i t3aa® short external hex parallel walled implant with dcdaa®, 5mm(d) x 5mm(l) (bnes505) was returned for investigation.Visual evaluation of the as returned product identified signs of use.Device history record (dhr) review was completed for the subject lot number (2021041301).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 (2021041301) for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: 3I T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 5MM(D) X 5MM(L)
• 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: 13891265
• Report Number: 0001038806-2022-00396
• Device Sequence Number: 11191100
• Product Code: DZE
• UDI-Device Identifier: 00844868033592
• UDI-Public: (01)00844868033592(17)260521(10)2021041301
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 05/21/2026
• Device Model Number: BNES505
• Device Catalogue Number: BNES505
• Device Lot Number: 2021041301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female