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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the elevator fractured, however it was not noticed until after the procedure.The patient is scheduled to return to the office for follow up to make sure the patient did not retain the fractured piece.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The exodontia elevator #46r serrated (part# 09-0252, lot# 022718b18) was visually evaluated.The elevator had some slight discoloring, likely a result of residue from the autoclave process.There was also some physical damage to the serrations on the tip of the elevator.The elevator was also clearly fractured at the distal end.Device history record (dhr) was reviewed and no discrepancies were found.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to the product experiencing excessive force during use.The instructions for use (ifu) for this product has the following information provided in the section titled warnings and precautions: when handling sharp instruments use extreme caution to avoid injury: avoid undue stress or strain when handling or cleaning instruments.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: date of this report, lot number, device availability, date received by manufacturer, type of report and follow-up number, follow-up type, device evaluated by manufacturer, device manufacture date 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: 7773778
• MDR Text Key: 116864769
• Report Number: 0001032347-2018-00539
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

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: 022718B18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 12/06/2018
• Supplement Dates FDA Received: 09/12/2018; 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1