MAUDE Adverse Event Report: BIOMET MICROFIXATION IQ DRIVER; BATTERY POWERED DRIVER

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The caution section of the instructions for use state, " always ensure that the driver blade/ drill is properly inserted into the collet by giving it a firm pull before use.Failure to properly insert a driver bit may result in injury to the patient, the user, or third party, damage to the driver, and may void the warranty." 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.This is report one of two for the same event.Report two of two is reported on mfr #: 0001032347-2017-00214.

Event Description

A distributor received a report that a blade fell out of an iq driver during a procedure after the device had already placed several screws.More information was requested but has not been received.

Manufacturer Narrative

The product identity was confirmed in the evaluation.Only the iq driver was returned.The most likely underlying cause of the complaint issue cannot be determined as the product has exceeded the expected lifecycle as determined by the manufacturer¿s warranty and was not tested.There are no indications of manufacturing defects.

• Brand Name: IQ DRIVER
• Type of Device: BATTERY POWERED DRIVER
• 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: 6419298
• MDR Text Key: 70424647
• Report Number: 0001032347-2017-00213
• Device Sequence Number: 1
• Product Code: GEY
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• 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: 72-1000
• Device Lot Number: 3D0182
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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