MAUDE Adverse Event Report: BIOMET MICROFIXATION IQ RAPID FIRE 1.5 MM HIGH TORQUE X-LOCK BLADE; IQ DRIVER BLADE

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." the product is still in use by the hospital and therefore will not be returned for an evaluation.Because the lot number is unknown, the device history records could not be pulled and reviewed.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.This is report two of two for the same event.Report one of two is reported on mfr #: 0001032347-2017-00213.

Event Description

A distributor received a report that a blade that 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.

• Brand Name: IQ RAPID FIRE 1.5 MM HIGH TORQUE X-LOCK BLADE
• Type of Device: IQ DRIVER BLADE
• 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: 6419262
• MDR Text Key: 70410597
• Report Number: 0001032347-2017-00214
• 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
• 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: 72-3200
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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