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 Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.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.(b)(4).

Event Description

It was reported just before christmas (the exact date is unknown) one of the elevator teeth broke while attempting to elevate/distract tooth number 16.The broken part of the elevator which was embedded was removed using a root pick.A two minute surgical delay was reported.The patient did not retain a foreign body.

Manufacturer Narrative

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 including a fractured tip; therefore, the complaint is confirmed.The most likely underlying cause of this complaint was determined to be 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." there are no indications of manufacturing defects.

• Brand Name: EXODONTIA ELEVATOR #46R SERRATED
• Type of Device: EXODONTIA 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: 6254247
• MDR Text Key: 64886257
• Report Number: 0001032347-2017-00042
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2016

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: Dentist
• Device Model Number: N/A
• Device Catalogue Number: 09-0252
• Device Lot Number: 110416J16
• Other Device ID Number: (01)00841036028152(10)110416J1
• 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: 12/28/2016
• Initial Date FDA Received: 01/16/2017
• 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: 11/08/2016
• 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