MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; TAP, BONE

Model Number	17109-055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device did not return for evaluation.Photographs were not provided; therefore, the complaint cannot be determined.Review of device history records indicates no manufacturing or processing irregularities that would cause or contribute to this failure mode." based on the information provided, a root cause cannot be determined.Multiple attempts have been made to obtain the device.If additional information and/or the device are provided, a supplemental report will be filled accordingly.
Event or Problem Description
It was reported that the tap was received with the tip broken off.There was no report of patient involvement.
Additional Manufacturer Narrative
Corrected information: d9.Yes, returned to manufacturer on 07/03/2024.H3.Yes.H6.Type of investigation: 10, 3331.Investigation findings: 3243.Investigation conclusions: 61.Additional information: visual inspection confirms two pieces of the distal tip have sheared off.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.The initial report stated there was no patient involved; however, previous complaints with sheared distal tips determined the root cause to be due to high torsional and bending loads.Review of device history records indicates no manufacturing or processing related irregularities.Warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.

• Brand Name: INVICTUS
• Common Device Name: TAP, BONE
• 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: 19627532
• Report Number: 2027467-2024-00070
• Device Sequence Number: 17992035
• Product Code: HWX
• UDI-Device Identifier: 00190376192079
• UDI-Public: (01)00190376192079(10)8786312
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: 17109-055
• Device Catalogue Number: 17109-055
• Device Lot Number: 8786312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown