MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø5.0X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative yukon polyaxial screw fracture.The associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
The screw was visually analyzed for macroscopic indications of failure mode.The fracture occurred immediately beneath the ball feature at the screw neck.The fracture surface was relatively level and the fracture plane was orthogonal to the screw axis.The fracture surface showed plastic deformation and helical distortion characteristic of ductile failure in torsion.The center of the helical distortion is slightly off-center with respect to the screw axis.The direction of the fracture dimples about the origin indicate the screw fractured during insertion.There is significant deformation on and material lost from the screw threads at the top of the shank, likely caused by the implement used to extract the screw after it fractured (i.E., pliers).Several chunks of the threads are missing near the distal point of the shank; this may have been caused during removal or during handling and transit after extraction.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history for the reported lot number was reviewed and no adverse trends were identified.The most likely root cause is stress beyond the structural capacity of the screw.Various factors may have contributed to the failure, including, but not limited to: screw diameter (larger screws require more torque to insert); application of off-axis forces; screw hole prep (under-tapping, not tapping, small drill size, shallow drilling depth, etc.); patient factors (bone quality, pathologies, etc.).

• Brand Name: POLYAXIAL SCREW; SIZE Ø5.0X26 MM
• Common Device Name: POSTERIOR CERVICAL 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: 15135739
• Report Number: 3004774118-2022-00301
• Device Sequence Number: 17451737
• Product Code: NKG
• UDI-Device Identifier: 10888857350007
• UDI-Public: 10888857350007
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 7601-05026
• Device Catalogue Number: 7601-05026
• Device Lot Number: JKCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2019
• 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