MAUDE Adverse Event Report: EBI, LLC POLARIS 5.5 STANDARD IMPLANT KIT; PLUG DRIVER

Model Number N/A

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 07/10/2014

Event Type  malfunction  

Event Description

It was reported the patient was fused and wanted the hardware removed.During the attempted removal the plug driver torqued and the tip twisted off.The surgery was successful and no adverse events were reported.

Manufacturer Narrative

A visual examination confirmed the reported event.The tip of the instrument is sheared off; the remaining portion of the tip is slightly deformed in a clockwise torquing/twisting manner.Due to the condition of the returned plug driver a functional evaluation was not performed.The rep stated this was a removal case and therefore deformation should be seen in a counter-clockwise direction; this instrument tip may have previously been damaged/deformed during tightening of the plug.A review of the device history records indicated that there were no dimensional, functional, or material anomalies reported at inspection.The probable underlying root cause for the damage is excessive torque forces leading to loss of mechanical integrity and ultimately instrument deformation and fracture during usage of the device.

• Brand Name: POLARIS 5.5 STANDARD IMPLANT KIT
• Type of Device: PLUG DRIVER
• Manufacturer (Section D): EBI, LLC; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle coldwater ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 3981560
• MDR Text Key: 22266877
• Report Number: 0002242816-2014-00061
• Device Sequence Number: 1
• Product Code: KWP
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• 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: 2000-9061
• Device Lot Number: PS52A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1