MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SINAL FIXATION SYSTEM; TAP, BONE

Model Number	17109-055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow-up report with results of the investigation will be submitted upon completion.
Event or Problem Description
The tip of a tap sheared off in the patient's pedicle.It was retrieved from the patient.
Additional Manufacturer Narrative
H6.Investigation conclusions: 4307; 61.H10.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.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 a 50mm groove.Physical measurements of the rma tap are nominal.Hardness was also confirmed at 47.2 hrc.This is a case of trying to laterally redirect too heavily with too much tap advancement.Not indicative of driving into hard bone.

• Brand Name: INVICTUS SINAL FIXATION SYSTEM
• Common Device Name: TAP, BONE
• Manufacturer (Section D): 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: 14342256
• Report Number: 2027467-2022-00027
• Device Sequence Number: 11944177
• Product Code: HWX
• UDI-Device Identifier: 00190376192079
• UDI-Public: (01)00190376192079(10)8289906
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/11/2022

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
• Device Model Number: 17109-055
• Device Catalogue Number: 17109-055
• Device Lot Number: 8289906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2013
• 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