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

Model Number	17109-055
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tap has not returned for evaluation.Photographs were provided which confirm the event.A review of the device history records could not be performed as the identifying lot number was not provided.Based on the information provided, a root cause could not be determined.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.
Event or Problem Description
During a spinal procedure, it was reported that the threaded portion of the cannulated tap broke off inside the patient's vertebral body.It was unable to be retrieved from the patient.There was no surgical delay.
Additional Manufacturer Narrative
Additional information: d4.Lot #: ng105220 corrected information: primary udi #: (b)(4).D9.Yes, returned to manufacturer: 10/15/2024 h3.Yes h6.Type of investigation: 10, 3331 investigation findings: 3243 investigation conclusions: 61 device evaluation: visual inspection confirms that there is damage to the distal tip of the tap.Portions of the tip broke off on one side of the tap.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 root cause is likely high torsional and bending loads placed on the tap.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: 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: 20452536
• Report Number: 2027467-2024-00124
• Device Sequence Number: 8559196
• Product Code: HWX
• UDI-Device Identifier: 00190376192079
• UDI-Public: (01)00190376192079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 17109-055
• Device Catalogue Number: 17109-055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown