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

Model Number	17170;17182
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device did not return for evaluation.No photographs were provided.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, the root cause could not be determined.
Event or Problem Description
It was reported a tower, closed top and tower pusher became cold welded together during a procedure.A metal cutting burr was used to separate them in order to fit a screwdriver down to remove/re-position a screw.There were no patient symptoms or complications reported as result of this event.The surgery was completed successfully.

• Brand Name: INVICTUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: wes channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18022017
• Report Number: 2027467-2023-00070
• Device Sequence Number: 17802907
• Product Code: LXH
• UDI-Device Identifier: 00190376268873
• UDI-Public: (01)00190376268835;(01)00190376268873
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/27/2023

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: 17170;17182
• Device Catalogue Number: 17170;17182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 52 YR
• Patient Sex: Male