MAUDE Adverse Event Report: GENESYS SPINE GENESYS SPINE APACHE® TLIF INTERBODY FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE

Model Number GT-09-SL

Device Problems Failure To Adhere Or Bond (1031); Disassembly (1168); Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

To implant a tlif it is first threaded onto an inserter.Due to a broken pin in the inserter the tlif was not fully threaded onto the inserter.When hammered into position (standard practice is to use a mallet to drive the interbody into the disk space) a small piece chipped off the tlif.This was a direct result from the tlif not being fully connected to the inserter.The chipped piece was retrieved and the remaining tlif was left in the patient at the physician's discretion.The tlif part # and lot # was gt-09-sl and ar20160721b.The inserter's part # and lot # are gp200 and 11578.The inserter was returned for inspection.Inspection of the returned inserter revealed that the spring pin used to join the tlif inserter shaft to the knob was missing.Investigation of the failure determined the following: a spring pin is used to join the tlif inserter shaft to the knob.A spring pin is a hollow pin made by rolling a piece of sheet metal into a short tube.Spring pins are easy to assemble since the hollow center allows them to deform inward.This allows spring pins to easily be pressed into position.Unfortunately, due to the hollow center spring pins are not the strongest type of pins.The tlif inserter shaft, the knob, and the spring pin are exposed to fairly high forces.When a tlif is inserted into the disk space a mallet is used to hammer the device in position.This creates a high shear force on the spring pin.When the tlif inserter is fully assembled the spring pin is not exposed on the device - it is hidden under the handle.Because of this fact the spring pin could not dislodge during clinical use.It is believed that over several years of use the spring pin in this device must have become deformed or fatigued to the point that it fell out of the assembly during cleaning or sterilization (when the device is disassembled).This represents a maintenance issue as the hospital cleaning staff and the sales rep are required to inspect the instruments for damage during cleaning and sterilization.The particular tlif inserter that failed had been in use since april of 2014.The design of the plif and alif inserters (gp100 & gp500 respectively) utilize the identical spring pin design as is used for the tlif inserters.With alif, plif, & tlif inserters being in use since 2011 and no prior failures associated with a deformed or missing spring pin this device malfunction is believed to be an isolated issue with a very low occurrence rate.

Event Description

Due to a malfunction with the implant's inserter a small piece of a peek interbody chipped off while the interbody was being advanced into the disk space.This piece was retrieved without incident and without any acute impact to the patient.The patient is proceeding with a normal post-op recovery following the surgeon's standard treatment regimen.The interbody was a tlif.

• Brand Name: GENESYS SPINE APACHE® TLIF INTERBODY FUSION SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): GENESYS SPINE; 1250 capital of tx hwy south; bld three, suite 600; austin TX 78746
• Manufacturer Contact: william sowers ; 1250 capital of tx hwy south; bld three, suite 600; austin, TX 78746 ; 5123817080
• MDR Report Key: 6051602
• MDR Text Key: 58201302
• Report Number: 3008455034-2016-00002
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: M719GT09SL0
• UDI-Public: +M719GT09SL0/$$7AR20160721BV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: GT-09-SL
• Device Lot Number: AR20160721B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GP200 INSERTER; PEDICLE SCREW CONSTRUCT
• Patient Age: 50 YR