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

Model Number	17139-055-N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned for evaluation.Photographs were provided which confirm the event of the tip breaking off of the rest of the device.The lot number was not provided; therefore, a review of device history records cannot be performed.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 filed accordingly.
Event or Problem Description
It was reported that the tip of the tap broke off into the patient's bone when reversing direction to remove it from the pedicle.The tip of the tap remains in the patient.There was a greater than 30 minute delay in surgery due to the event.
Additional Manufacturer Narrative
Corrected information: d4.Primary udi: (b)(4).D9.Yes, returned to manufacturer: 07/03/2024.H3.Yes.H6.Type of investigation: 10, 3331.Investigation findings: 3252.Investigation conclusions: 22.Additional information: d4.Lot #: 8698308r.H4.03/17/21.Visual inspection confirms the tip of the tap has sheared off at the 50mm fluoro groove.The failure is likely due to attempt in re-direction of the tap too heavily with too much tap advancement.Review of device history records showed no manufacturing or processing related irregularities that would cause or contribute to this failure mode.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 affects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.

• 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: 19634495
• Report Number: 2027467-2024-00071
• Device Sequence Number: 8535492
• Product Code: OLO
• UDI-Device Identifier: 00190376319223
• UDI-Public: (01)00190376319223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 17139-055-N
• Device Catalogue Number: 17139-055-N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/12/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male