MAUDE Adverse Event Report: ALPHATEC SPINE, ALPHATEC NAVIGATION INSTRUMENTS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	17139-055-N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
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.A review of the device history record did not identify any manufacturing or processing related irregularities.The 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 50mm groove.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.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 surgeon used the tap, and it broke off in the vertebral body.It was reported the patient had very hard bone.The surgeon was able to retrieve the tap tip from the patient; however, it did cause a delay in surgery.

• Brand Name: ALPHATEC NAVIGATION INSTRUMENTS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ALPHATEC SPINE,; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 13958208
• Report Number: 2027467-2022-00010
• Device Sequence Number: 14673125
• Product Code: OLO
• UDI-Device Identifier: 00190376319223
• UDI-Public: 00190376319223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153603
• 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): 02/28/2022

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
• Device Model Number: 17139-055-N
• Device Catalogue Number: 17139-055-N
• Device Lot Number: 8698308R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male