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

Model Number	17010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The second polyaxial screwdriver used in the case is of the same product part number/description but contains separate identifying lot number.8406901 manufactured 11/10/2019.The evidence indicates that the driver was not fully engaged and/or possibly not coaxial to the screws during attempted insertion.This resulted in only the distal ends of the drivers being loaded and deforming, which in turn broke off the stop component from the shaft.
Event or Problem Description
Two screwdrivers broke while inserting an illiac screw.The event caused over a 30 minute delay in the case.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10515760
• Report Number: 2027467-2020-00036
• Device Sequence Number: 14129567
• Product Code: HXX
• UDI-Device Identifier: 00190376192802
• UDI-Public: (01)00190376192802(10)8299301
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/12/2020

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: 17010
• Device Catalogue Number: 17010
• Device Lot Number: 8299301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other