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

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 08/18/2016

Event Type  malfunction  

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 the elevator broke during a procedure.It is reported that all parts were retrieved and there was a delay of a few minutes with no injury to the patient.It is confirmed the tip was not embedded in the patient and did not require surgical intervention to retrieve it.

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 was returned for evaluation.The product identity was confirmed in the evaluation.Visual inspection reveals mild use.Upon examination of the product, it is clearly visible that the tip of the elevator is fractured; therefore the complaint is confirmed.The most likely underlying cause of this complaint was determined to be excessive force.The customer most likely applied excessive force to the tip of this instrument in an attempt to extract a tooth.The device history records for this product's lot was reviewed in the evaluation and no non-conformance was found.According to the evaluation, there are no indications of manufacturing defects based on the evaluation, the following were updated: date received by mfr, if follow-up, what type?, device evaluated by mfr?, evaluation codes, and additional mfr narrative.

• Brand Name: EXODONTIA ELEVEVATOR #46 R 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: 6151124
• MDR Text Key: 61727326
• Report Number: 0001032347-2016-00741
• 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: 11/15/2016

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: 060616E16
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/11/2017; 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1