MAUDE Adverse Event Report: BIOMET MICROFIXATION EXODONTIA ELEVATOR #46R, SERRATED; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the instrument fractured.Attempts have been made to gather more information and none has been provided.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint cannot be verified.Functional testing and inspections could not be performed due to the product not being returned and no photographs being provided.The dhrs will not be reviewed as the lot numbers remain unknown.There are no indications of manufacturing defects.For this part (09-0252) and the previous two years (from the notification date) regarding the tip fracturing, there is a complaint rate of (b)(4) , which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: date of this report, describe event or problem, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, method code, results code, conclusions code, and additional narratives/data.

• Brand Name: EXODONTIA ELEVATOR #46R, SERRATED
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9428560
• MDR Text Key: 191996085
• Report Number: 0001032347-2019-00547
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028152
• UDI-Public: 00841036028152
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0252
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1