MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR; ELEVATOR #301

Model Number N/A

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The customer reported the elevator broke in a patient's mouth, the piece was removed and no adverse effects were reported as a result of this event.

Manufacturer Narrative

A review of the non-conformance database was conducted and there were no documented deviations for this lot.The package insert states "the tip of the instrument is extremely thin and delicate, care should be taken to avoid applying significant pressure to the tip.If excessive pressure is applied to the tip of the instrument, it will bend, rendering it useless.This elevator is not intended for use when removing a tooth that is not loose in the socket." upon evaluation, the tip of the instrument was found to be chipped and the fragmented piece was not returned.There were no indications of manufacturing defects.The most likely underlying cause of the complaint issue is excessive force applied by the user.There are no adverse effects reported as a result of this event, however, the device malfunction is subject to the two year rule.

• Brand Name: ELEVATOR
• Type of Device: ELEVATOR #301
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: amanda sisk ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4064366
• MDR Text Key: 17626322
• Report Number: 0001032347-2014-00297
• 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: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2014

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: 09-0257
• Device Lot Number: 013113A13
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2013
• 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