MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS SPINAL FIXATION SYSTEM; PROBE

Model Number	17001-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned instrument confirmed the distal tip of the probe has sheared off.The curved probe is used to create a pilot hole in the pedicle prior to implanting a screw and as such must be malleted into the bone.The distal tip contains the smallest diameter on the instrument and is subject to the most stress during use.When used as intended the instrument would not encounter the amount of force required to fracture the tip in this manner.The instrument conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.
Event or Problem Description
It was reported the tip of the probe broke off during use.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: PROBE
• 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: 17381192
• Report Number: 2027467-2023-00047
• Device Sequence Number: 17687794
• Product Code: HXB
• UDI-Device Identifier: 00190376195643
• UDI-Public: (01)00190376195643(10)8698502
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 17001-01
• Device Catalogue Number: 17001-01
• Device Lot Number: 8698502
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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