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 instrument is fractured at the tip.It is unknown if the tip broke during a procedure or had any impact on a patient.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection show signs of moderate wear.Upon inspection, it can be seen that the elevator is fractured at the distal end.There are no indications of manufacturing defects.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the product experienced forces in excess of what it was designed to encounter.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.(b)(4).

• 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: 7441677
• MDR Text Key: 106256992
• Report Number: 0001032347-2018-00210
• 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: 08/21/2018

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: Dentist
• Device Model Number: N/A
• Device Catalogue Number: 09-0252
• Device Lot Number: 060717E17
• Other Device ID Number: (01)00841036028152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 04/25/2018; 07/26/2018
• Supplement Dates FDA Received: 05/25/2018; 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1