MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	BOSS410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Additional device information unknown / not provided.Device manufacturer date unknown / not provided.
Event or Problem Description
Doctor reported that during implantation at tooth site 13 the vestibular bone slat fractured.No other implant was placed to complete the procedure.Patient has been rescheduled for new implantation after healing.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Product evaluation: one implant was returned for investigation.Visual evaluation of the as returned product identified signs of use with bone debris on external threads.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.The implant could not be functionally tested for the reported event (bone fracture).A pre-existing condition were not noted as normal on the per form.Bone density was high density (type i).The reported device was located on tooth location # 13 (fdi) and was implanted and explanted on the same day.X-ray & picture evaluation: the customer did not provide any images for the reported event.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j - 1/8/2022.Information identified: contraindications, warnings, precautions, and potential adverse events.Per the applicable ifu, improper techniques may lead to implant failure and forcing the implant into the osteotomy deeper than the depth established by the drills can result in damage/fracture.Dhr review: dhr review was completed for the subject lot number 2022031751.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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: complaint history review was performed for the reported lot number 2022031751 for similar events and no other complaint was identified.Review completed utilizing keywords: 'dental : medical : bone fracture.' post market trending review: january post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.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 has not occurred and the reported event was non-verifiable.

• Brand Name: 3I T3¿ NON-PLATFORM SWITCHED PARALLEL WALLED 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: 15980518
• Report Number: 0001038806-2022-01904
• Device Sequence Number: 15183974
• Product Code: DZE
• UDI-Device Identifier: 00844868028819
• UDI-Public: (01)00844868028819(17)270503(10)2022031751
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 04/11/2023

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: Health Professional
• Device Model Number: BOSS410
• Device Catalogue Number: BOSS410
• Device Lot Number: 2022031751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male