MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	17139-055-N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of a tap bent during surgery.There were no reported patient complications.
Additional Manufacturer Narrative
The device was used for treatment, not diagnosis.Taps may be used during pedicle preparation to facilitate screw insertion.The cannulation of the tap (through hole) is slid over the guidewire after the site has been dilated to the appropriate diameter.The bone is then tapped to the desired depth.Taps come in 4.5 mm, 5.5mm, 6.5 mm & 7.5 mm and are color coded by diameter.The initial report indicated the tip of the tap was bent.Visual inspection of the returned tap determined a portion of the tap was broken off.The break is angled, ununiform and jagged.Broken pieces not returned with instrument.No other observable signs of damage on remainder of instrument other than cosmetic scratches.Taps which fail due to purely torsional loads will experience distal twisting and/or shear fracture, typically proximal of the threads at the smaller end of the instrument.The fragmentation and angle of this tap fracture can only be achieved with large torsional loads accompanied by large bending loads.

• Brand Name: INVICTUS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16882318
• Report Number: 2027467-2023-00036
• Device Sequence Number: 7256656
• Product Code: OLO
• UDI-Device Identifier: 00190376319223
• UDI-Public: (01)00190376319223(10)8698308R
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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 Model Number: 17139-055-N
• Device Catalogue Number: 17139-055-N
• Device Lot Number: 8698308R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown