MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 6/5 X 8.5MM; DENTAL IMPLANT

Model Number	BOPT6585
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during restoration, the patient¿s general dentist used a non-zimvie abutment/screw with a zimvie implant which resulted in the dentist failing to complete the restoration due to complications of the screw used.The patient was then referred back to the surgeon to have the screw removed.Two attempts were made with no success of removing the screw.The general dentist was advised that they could not move forward with seeing the patient again to complete the final restoration.The recommendation provided to the patient as the only alternative was to have the whole implant removed and unfortunately start over.The implant at tooth location #14 was removed and the patient will return for future implant placement.  note: the manufacturer of the non-zimvie abutment/screw is unknown.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 3331, 4109 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67 and 4315.H10: narrative/data was updated.One (1) 3i t3 tapered implant 6/5 x 8.5mm (bopt6585) was returned for investigation.Visual evaluation of the as returned product identified no damage or signs of malfunction that would contribute to the event.Damage identified from the removal process.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimvie.Dhr review was completed for the subject lot number 2020120526.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 was performed for the reported lot number 2020120526 for similar events and no other complaint was identified.Functional testing for the returned product was performed.It was confirmed that there were no malfunctions identified.Based on the investigation, the probable root causes are not applicable to the reported event since a device malfunction did not occur.The event was unconfirmed through visual and physical inspection.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: 3I T3 TAPERED IMPLANT 6/5 X 8.5MM
• 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: 16385054
• Report Number: 0001038806-2023-00301
• Device Sequence Number: 20212387
• Product Code: DZE
• UDI-Device Identifier: 00844868029892
• UDI-Public: (01)00844868029892(17)260107(10)2020120526
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2026
• Device Model Number: BOPT6585
• Device Catalogue Number: BOPT6585
• Device Lot Number: 2020120526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male