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

Model Number 15311-35; 16021

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

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

Inserter ((b)(4)) completely broke off at the tip and driver threads were then stuck within the cross connector.The cross connector ((b)(4)) completely disassembled on the mayo when loosening.It was loosened to secure it onto the rod.

Manufacturer Narrative

A review of the device history records found no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.An evaluation of the universal cross connector inserter was conducted.The tip of the instrument is missing.All other features of the instrument appear to be in-spec an unimpacted by the failure.Wear marks at cross sectional area where the failure occurred indicate the hexalobe sheared due to user-applied torsional force.During the insertion process, the surgeon over-torqued the implant greater than 40 in-lb and likely yielded the twisted hex.The inserter is indicated only to insert and hand tighten the implant to the construct (not apply forces >40 in-lb).When the surgeon attempted to remove the final tightened implant with the 40 in-lb final torque handle, the torque required was greater than ~50in/lb and the handle was unable to apply sufficient reverse torque.He then deferred to the twisted hexalobe inserter and attempted to use it to untighten the implant, which is not an indication of use for the instrument.He then applied enough torque (~50-60 in-lb) to yield and shear the twisted hex.The implant was received in disassembled unilaterally.Wear on the locking nut indicates that the locking pin bottomed out as intended.Locking pins are sheared.The surgeon backed the implant up until the locking pin bottomed out on the locking nut shoulder as intended.Increased reverse torque was applied until the pin sheared and the implant was able to be disassembled.Once the pin shears, all components on the affected side are able to disassemble.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11969212
• MDR Text Key: 262001629
• Report Number: 2027467-2021-00036
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K203056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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: 15311-35; 16021
• Device Catalogue Number: 15311-35; 16021
• Device Lot Number: 8693301; 8702905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1