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

Model Number	17139-045-N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Taps come in 4.5 mm, 5.5mm, 6.5 mm & 7.5 mm and are color coded by diameter.Review of the device history records did not identify any manufacturing or processing related irregularities.The tap was found to be properly manufactured and released in accordance with design specifications.There were no issues during the manufacture of this product that would contribute to this complaint condition.The instrument was manufactured from 465ss (stainless steel) and is certified to astm a564 specifications.The initial report stated the tip of the tap was bent.Visual inspection of the tap, it was identified the distal tip was fractured and became separated from the instrument.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.It appears that the tip fracture was likely the result of use in hard dense bone, which required an increased torsional load that exceeded the design limits of the instrument.
Event or Problem Description
It was reported the tip of a 4.5mm tap, cannulated, navigation is bent.

• Brand Name: ALPHATEC NAVIGATION INSTRUMENTS
• Common Device Name: ORTHOPEDIC STEREOTAXIC 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: 17397532
• Report Number: 2027467-2023-00051
• Device Sequence Number: 7556173
• Product Code: OLO
• UDI-Device Identifier: 00190376319209
• UDI-Public: (01)00190376319209(10)MB9067810
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/25/2023

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: 17139-045-N
• Device Catalogue Number: 17139-045-N
• Device Lot Number: MB9067810
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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