MAUDE Adverse Event Report: BIOMET 3I NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 4(L)

Catalog Number MSGIIM4

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Age: not provided.Patient weight: not provided.Device lot number: not provided.Device not returned.

Event Description

It was reported that a navigator® certain® implant mount screw (msgiim4) fractured within the implant.Fractured piece was removed and implant is intact.No delay or serious injury has been reported.Tooth location 26.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

A navigator® certain® implant mounts, 3.4mm(d) x 4(l) (item # (b)(4)) and was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information using the item #/ item # and lot # (dhr/ifu/rmf).No pre-existing conditions were noted on the per.The reported device was located on tooth #(b)(6) and was used for an unknown period of time.Pictures or x-ray images were not provided.Dhr review and complaint history review could not be performed for the reported (b)(4) , as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the (item # (b)(4)) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformance/capa/hhe/d/ie/product holds for the reported device related to the reported event.December post market trending was reviewed and there were no actionable events or corrective actions for the reported event (screw fracture) or devices ((b)(4)).Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.A definitive cause could not be identified.

• Brand Name: NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 4(L)
• Type of Device: IMPLANT MOUNT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9499782
• MDR Text Key: 176270832
• Report Number: 0001038806-2019-01657
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MSGIIM4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1