MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	BNSS313
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that driver tip did not disengage from the implant.Procedure has been completed using another device.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by the manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative product evaluation: one implant and one driver tip were returned for investigation.Visual evaluation of the as returned device identified signs of use (bone and blood residue around the external threads of the implant).The two (2) devices were attached to each other and could not be separated.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition was not recorded on the per form.Bone density type is unknown.The reported implant was located on an unknown tooth site and was used for an unknown amount of time.X-ray & picture evaluation: the customer did not provide any images for the reported event.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (biomet 3i dental implant ifu (p-iis086gi) rev j - 1/8/2022.Instructions for use for biomet 3i kits and instruments (p-zbdinstrp), rev e 1/4/2022.Information identified: warnings and precautions per the applicable ifu, it is stated that surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including prolonged use, misuse, and rough or improper handling.Care must be taken to avoid compromising their performance.Dhr review: (bnss313) dhr review for the lot 2018021839 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: complaint history review was performed for the reported lot number 2018021839 for similar events and no other complaint was identified.Review completed utilizing keywords: 'functional : does not disengage/release' dhr review: (impdtl) dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported product are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review: a complaint history review by item number was conducted for the (impdtl) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Review completed utilizing keywords: 'functional : does not disengage/release' post market trend review: december 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.Based on the available information, a 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¿ NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 13MM
• 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: 15553335
• Report Number: 0001038806-2022-01526
• Device Sequence Number: 5959102
• Product Code: DZE
• UDI-Device Identifier: 00844868028994
• UDI-Public: (01)00844868028994(17)230309(10)2018021839
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/27/2023

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: 03/09/2023
• Device Model Number: BNSS313
• Device Catalogue Number: BNSS313
• Device Lot Number: 2018021839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2018
• 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 Sex: Male