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

Model Number	17139-045-N
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tip of the tap was broken within the patient's bone.Although the polyaxial screws are self-tapping, taps may be used during pedicle preparation to facilitate screw insertion.The cannulation of the tap (through hole) is slid over the guidewire after the site has been dilated to the appropriate diameter.The bone is then tapped to the desired depth.Cannulated taps in the set come in 4.5 mm, 5.5mm, 6.5 mm & 7.5 mm and are color coded by diameter (reference stg lit-(b)(4)).A review of the device history record did not identify any manufacturing or processing related irregularities.The invictus mis tap was found to be properly manufactured and released in accordance with design specifications.An evaluation found that the distal tip had fractured and became separated from the instrument at the 60mm laser line.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.The distal shaft is also slightly bent, indicating that the user pried on the tap with the tap already deep in bone.The combination of torsional overload and prying off axis with the tap in bone, cause the tap to break.The detached tip, was able to be removed from the patient.It appears that this occurrence is likely the result of implantation in hard dense bone, which required an increased torsional load and off axis force that exceeded the design limits of the instrument.
Event or Problem Description
The doctor attempted to back out the tap and heard a snap.The doctor looked down and realized the tap had snapped 20mm above the threads.This caused a delay in surgery of greater than 30 minutes.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: HWX
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11784834
• Report Number: 2027467-2021-00022
• Device Sequence Number: 11633201
• Product Code: HWX
• UDI-Device Identifier: 00190376319209
• UDI-Public: (01)00190376319209(10)8698307R1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/07/2021

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: 17139-045-N
• Device Catalogue Number: 17139-045-N
• Device Lot Number: 8698307R1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 05/06/2021
• 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
• Patient Age: 70 YR