MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 15004-105-100

Device Problems Break (1069); Noise, Audible (3273)

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

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

The returned implant is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.

Event Description

Upon inserting screws into bone, the screw driver made a cracking noise as the screw advanced into hard bone.The winged tip of the screw driver sheared off and the driver fell apart.This caused the screw shank to strip and the bushing to break, subsequently resulting in cutting off the head of the screw to extract the shank separately.The second driver broke while inserting the other s2ai screw.The surgeon attempt to helicopter the screw down the rest of the way with the counter torque and the screw head sheared off.The detached tulip/screw head was removed but the threaded shank remains entrapped within s2ai (sacral alar iliac).The event caused over a 30 minute delay in the case.

Manufacturer Narrative

The returned driver shafts some deformation of the hexalobe tip at the most distal end.When the driver hexalobe is fully engaged, the failure mode is a complete shear of the driver hexalobe vs deformation of the distal end.The deformation being isolated at the distal end indicates that the screwdriver hexalobe was not fully engaged in the screw (female) hexalobe during screw insertion.Further investigation of the shaft deformation shows an angled wear contact on the hexalobe, indicating that the screwdriver was not coaxial to the screw during insertion.This results in only the distal end being loaded and deforming.It is expected that the mating screw hexalobe (female) is damaged in the process which was confirmed as part of the complaint report (screw shank components were not explanted for investigation).The returned (broken) screwdrivers had the stop component broken.The stop component is an alignment feature and not intended to withstand torque.Torque from screw shank to screwdriver is transmitted through the hexalobe interaction between screw shank and shaft.If the hexalobe interaction is stripped or compromised, the torque is transmitted directly through the stop component to the screw components.The explant screws were both polyaxial tulips where the tulip/bushing can freely rotate about the screw shank.Therefore, even if the screwdriver hexalobe was stripped or compromised, there should be little to no torque resulting between the screwdriver stop and the tulip components.For the stop component to break while applying torque, the screw polyaxial tulip must be constrained either externally or potentially constrained by the shank due to extreme angle insertion.1 of explanted tulips was returned disassembled (bushing, cam explant also returned).The tulip component did show a wear marks at the rod slot surface located at the region where the screwdriver stop component would interfere.There was no other significant findings, except for the material removal that was purposely done for explant.The second explanted tulip was returned assembled with a rod and set screw.This screw shank sheared at the base of the hexalobe due to high torque insertion into hard bone, as described in the report.The insertion method of using a rod to drive the screw in is not the intended use.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 9835213
• MDR Text Key: 189654982
• Report Number: 2027467-2020-00019
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376136998
• UDI-Public: (01)00190376136998(10)8367311
• Combination Product (y/n): N
• PMA/PMN Number: K181677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15004-105-100
• Device Catalogue Number: 15004-105-100
• Device Lot Number: 8367311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR