MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD MAXAN GREEN QUICK ADJUSTMENT DRIVER

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

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 was reported while attempting to back out a screw with the quick adjustment driver the blue handle began to rotate independently of the driver shaft.The case was a new acdf (anterior cervical discectomy and fusion) at the level below an existing construct.The original plate was only removed to accommodate single level plate placement at the new level being treated.

Manufacturer Narrative

The returned adjustment driver was evaluated.The handle is starting to unthread from the shaft; the complaint is confirmed.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain specific instructions regarding screw removal: a screw remover is to be used, not the adjustment driver.The threads on the screw remover are opposite those on the adjustment driver so that the handle will not separate from the shaft during screw removal.Therefore, this event has been determined to have been caused by the user not following labeling instructions.

• Brand Name: MAXAN GREEN QUICK ADJUSTMENT DRIVER
• Type of Device: QUICK ADJUSTMENT DRIVER
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5985848
• MDR Text Key: 55878041
• Report Number: 3004485144-2016-00254
• Device Sequence Number: 1
• Product Code: KWQ
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• 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: 14-521002
• Device Lot Number: PR67A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2009
• 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