MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 7.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-07545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery to revisit a construct, an everest polyaxial screw fractured at the shaft.The surgeon decided to leave the broken shaft insitu and linked the rod from l4-s1 without l5 fixation as there were still three points of fixation on the right side.There were no adverse consequences to the patient.The procedure was completed successfully with a 15-minute surgical delay.
Event or Problem Description
It was reported that during a revision surgery to revisit a construct, an everest polyaxial screw fractured at the shaft.The surgeon decided to leave the broken shaft insitu and linked the rod from l4-s1 without l5 fixation as there were still three points of fixation on the right side.There were no adverse consequences to the patient.The procedure was completed successfully with a 15-minute surgical delay.
Additional Manufacturer Narrative
The returned device was visually inspected and the fracture was confirmed.The fractured screwhead was firmly stuck on the distal tip of the implanting instrument.Deformation of the instrument threads and the screwhead indicate excessive force could have been used, causing the implant and instrument to bind together.Complaint history records were reviewed for this lot and no relevant manufacturing issues or similar complaints were identified.Per the ifu: unlocking and removal once the set screw in either the everest screw or everest hook has been final tightened, it may be loosened using the set screw removal wrench.This instrument ratchets when it is turned in a clockwise direction, so it will not function as a final tightener.Insert the removal wrench through the anti-torque device and turn the handle of the instrument counter-clockwise to loosen the everest set screw.The screw may be removed with the driver and t-handle.Engage the driver tip with the inner hexalobe of the implant and turn in a counter-clockwise direction to remove the screw (p.32).It was confirmed that the surgeon did not tap prior to inserting the screw.The most likely root cause is a combination of not tapping and the patient having especially hard bone.

• Brand Name: POLYAXIAL SCREW; SIZE 7.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11215856
• Report Number: 3004774118-2021-00017
• Device Sequence Number: 19694441
• Product Code: NKB
• UDI-Device Identifier: 10888857042698
• UDI-Public: 10888857042698
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 2911-07545
• Device Catalogue Number: 2911-07545
• Device Lot Number: MUUG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 01/03/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1