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

Model Number 17001-01

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

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 Description

It was reported the tip of the probe broke off during use.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: 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
• MDR Text Key: 319961804
• Report Number: 2027467-2023-00047
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00190376195643
• UDI-Public: (01)00190376195643(10)8698502
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17001-01
• Device Catalogue Number: 17001-01
• Device Lot Number: 8698502
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1