MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SPINAL FIXATION SYSTEM; HXX

Model Number 17111

Device Problems Use of Device Problem (1670); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event Description

The tip of the mis reduction polyaxial screwdriver sheared off when attempting to implant a pedicle screw.There was no impact to the patient.

Manufacturer Narrative

Review of the device history records did not identify any manufacturing or processing related irregularities.The invictus mis reduction polyaxial screwdriver, locking was found to be properly manufactured and released in accordance with design specifications.The mis reduction polyaxial screwdriver, locking returned to atec on 03/24/2021.Visual inspection indicates a clean shear fracture of the driver hexalobe tip.No other remarkable features or observations were identified.The root cause is likely physical damage due to excessive torque which resulted in the tip shearing off.No patient injury reported.Labeling review: "possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.".

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11682723
• MDR Text Key: 248172192
• Report Number: 2027467-2021-00017
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00190376192710
• UDI-Public: (01)00190376192710(10)8522701
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17111
• Device Catalogue Number: 17111
• Device Lot Number: 8522701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other