MAUDE Adverse Event Report: BIOMET 3I 3I T3® EX HEX TAPERED IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	BOET410
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the cover screw does not screw inside the implant and was removed.Another implant has been placed.
Event or Problem Description
No further event information is available at the time of the 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: expiration date 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 3i t3a® ex hex tapered implant 4 x 10mm (boet410) was returned for investigation.The associated cover screw was reported but not returned.Visual evaluation of the as returned product identified bone residue on the device (due to usage) and damaged internal drive feature.Functional testing was performed with an in-house mating device which could not screw into/assemble with the implant since the drive feature (internal threads) were damaged.Device history record (dhr) review for the lot (2020011904) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2020011904) for similar events (complaint category keywords: does not assemble) and no other complaint was identified.Therefore, based on the available information, device malfunction did occur for the implant and the reported event was confirmed.However, device malfunction could not be verified for the cover screw since it was not returned.

• Brand Name: 3I T3® EX HEX TAPERED IMPLANT 4 X 10MM
• 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: 14191777
• Report Number: 0001038806-2022-00575
• Device Sequence Number: 4332944
• Product Code: DZE
• UDI-Device Identifier: 00844868033257
• UDI-Public: (01)00844868033257(17)250214(10)2020011904
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• 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,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 02/14/2025
• Device Model Number: BOET410
• Device Catalogue Number: BOET410
• Device Lot Number: 2020011904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male