MAUDE Adverse Event Report: BIOMET MICROFIXATION EXODONTIA ELEVATOR #46R SERRATED

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Because the lot number is unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the tip of an elevator broke during a procedure.It is reported the event caused a five minute delay.It is reported the elevator was placed between teeth fifteen and sixteen while trying to elevate/ extract tooth number sixteen.It is reported the surgeon was turning the elevator clockwise when the elevator broke.It is reported that a portion of the elevator was embedded in the patient when it broke.It is reported the embedded piece was removed by, "reflected gingiva's manipulated out.".

Manufacturer Narrative

(b)(4).Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The product identity was confirmed in the evaluation.Visual inspection reveals signs of use and a fractured tip; therefore the complaint is confirmed.The most likely underlying cause of this complaint is excessive force.It is possible that the customer applied excessive force to the tip of the instrument during tooth extraction.The instructions for use for this product states, "avoid undue stress or strain when handling or cleaning instruments." the device history records of this product's lot was reviewed and no non-conformance was found.There are no indications of manufacturing defects.

• Brand Name: EXODONTIA ELEVATOR #46R SERRATED
• Type of Device: ELEVATOR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6247303
• MDR Text Key: 64672149
• Report Number: 0001032347-2017-00031
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0252
• Device Lot Number: 110416J16
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/17/2017; 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention