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

Model Number	BNET410
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp (b)(4).Weight unknown / not provided.
Event or Problem Description
Doctor reported that when the doctor was placing the implant, the mount does not disengaged from the implant.Doctor did not finished the procedure and patient will have to return for the implant placement in a later point of time.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: d4: unique identifier (udi) number changed to unknown one 3i t3® with dcd® ex hex tapered implant 4 x 10mm (bnet410) with mount was returned for investigation.Visual evaluation of the as returned product identified some signs of usage due to stuck mount.The hex of the screw identified damaged/rounded as well.Device history record (dhr) review for the lot number (2015051477) 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.Complaint history review by lot number (2015051477) was performed for similar events and no complaint about nonconforming products was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 WITH DCD 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
• MDR Report Key: 10790598
• Report Number: 0001038806-2020-01734
• Device Sequence Number: 13735209
• Product Code: DZE
• UDI-Device Identifier: 00844868033059
• UDI-Public: (01)00844868033059(17)200619(10)2015051477(241)BNET410
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/19/2020
• Device Model Number: BNET410
• Device Catalogue Number: BNET410
• Device Lot Number: 2015051477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR