MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø8.5X80 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-08580
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during screw insertion, the non-advancing everest polyaxial screw became stripped, making it difficult to remove.A rod and set screw were used in attempt to counter torque the screw out of the pedicle.However, the everest polyaxial screw fractured at the shaft, just below the tulip.The procedure was completed successfully with a 40 minute surgical delay.No adverse consequences were reported.
Additional Manufacturer Narrative
The returned everest polyaxial screw was visually inspected.The screw was confirmed to be fractured just below the tulip head.This portion of the screw would experience the highlest load from the excessive torsional force used in attempt to remove the screw.Inside the screw head, the hexalobe shape was observed to be slightly deformed, likely from engaging with the instruments in order to insert/remove the screw from the patient's bone.The returned associated set screw was able to assemble and disassemble from the tulip threads.Complaint history records were reviewed for this lot, no similar complaints were identified.The patient's bone was reported to be very sclerotic, and there was difficulty with inserting the screw.The ratcheting t-handle's ratchet started to skip during the insertion.The screw stopped advancing and was stuck halfway inserted.The surgeon decided to remove the screw in order to tap with a higher diameter tap (8.5mm).The cannulated height adjustment driver was inserted into the screw head and was attempted to be used to remove the screw when the tip of the driver fractured.Another inserter was attempted to engage the screw head, but could not be properly seated due to the screws hex shape being deformed from the initial insertion.Due to this, a short rod (5.5x30 mm) was seated into the screw head, followed by a set screw initially tightened, and a counter-torque attached in an attempt to remove the screw from the patient.The screw's shaft fractured below the tulip during this maneuver.A non-stryker removal tool was used in attempt to remove the broken screw but was unsuccessful.The surgeon used a 3.0mm metal burr cutter and cut the screw to be flush with the patient's psis.The surgeon then placed a 8.5x70mm screw inferior to the broken screw using navigation.The most likely cause of the device fracture can be attributed to the patient's sclerotic bone condition and attributed forces in attempt to remove the screw.This abnormal increase in hardening and density of the patient's bone would require higher force to insert or remove a pedicle screw.The screw was likely torqued over the recommended value in order to remove the screw to adjust for the patient's bone quality.
Event or Problem Description
It was reported that during screw insertion, the non-advancing everest polyaxial screw became stripped, making it difficult to remove.A rod and set screw were used in attempt to counter torque the screw out of the pedicle.However, the everest polyaxial screw fractured at the shaft, just below the tulip.The procedure was completed successfully with a 40 minute surgical delay.No adverse consequences were reported.

• Brand Name: POLYAXIAL SCREW; SIZE Ø8.5X80 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12811870
• Report Number: 3004774118-2021-00355
• Device Sequence Number: 14609857
• Product Code: NKB
• UDI-Device Identifier: 10888857043190
• UDI-Public: 10888857043190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2911-08580
• Device Catalogue Number: 2911-08580
• Device Lot Number: PYCH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown