MAUDE Adverse Event Report: BIOMET MICROFIXATION IQ DRIVER; MOTORIZED DRIVER

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The part number, lot number, and quantity of screws is unknown; if the product information is received a medwatch will be submitted.Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state, "care must be taken to avoid over tightening of screws.Intraoperative fracture or stripping of screws can occur if additional activations are applied while seating the screws, or additional torque is provided to the screw using a hand-held driver." 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.

Event Description

It is reported that during a cranioplasty, the iq driver was over torquing and causing the screws to strip.The event caused a delay of five minutes.The procedure was completed with another iq driver.The patient did not retain a foreign body.It is reported the surgical technique for the product was utilized in this event.Additional information was requested but has yet to be received.

Manufacturer Narrative

The product identity has been confirmed in the evaluation.Upon visual inspection, the driver has some wear and tear from use.The driver was sent to the vendor for further evaluation and repair.The vendor could not find any problem with the motor activity; therefore the complaint is unconfirmed.The most likely underlying cause of the complaint is determined to be user error.There are no indications of a manufacturing defect.

• Brand Name: IQ DRIVER
• Type of Device: MOTORIZED 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: 6353393
• MDR Text Key: 68157690
• Report Number: 0001032347-2017-00123
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• 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: 5E0013
• Other Device ID Number: (01)00841036140175(10)5E0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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