MAUDE Adverse Event Report: BIOMET 3I 3I T3 NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	BOSS311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.
Event or Problem Description
Doctor reported implant boss311 fracture at tooth site 16.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) 3i t3® non-platform switched parallel walled implant 3.25 x 11.5mm (boss311) was returned for investigation.Visual evaluation of the as returned product identified the device fractured at the collar.The device also can be seen severely damaged around the threads, probably from the removal process.The non-reported screw was attached to the top portion of the implant and was also seen with signs of wear.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.(fracture) pre-existing condition noted on the per form was unknown bone density type.The reported device was located on tooth # 16 (fdi) and was used for approximately 6 years 3 months.The customer did not provide any pictures or x-rays.Device history review (dhr) review was completed for the subject lot number (2013111051).It was confirmed that all operations and inspections were executed as per the applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was 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 (2013111051) for a similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has occurred 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 NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10244392
• Report Number: 0001038806-2020-00952
• Device Sequence Number: 16942582
• Product Code: DZE
• UDI-Device Identifier: 00844868028765
• UDI-Public: (01)00844868028765(17)181203(10)2013111051(241)BOSS311
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2018
• Device Model Number: BOSS311
• Device Catalogue Number: BOSS311
• Device Lot Number: 2013111051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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: 42 YR