MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE Ø5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 yukon polyaxial screws fractured intra-operatively.Surgery was successfully completed with an unknown delay.No adverse consequences or medical intervention were reported.This report will capture the second of two screws.
Event or Problem Description
It was reported that 2 yukon polyaxial screws fractured intra-operatively during screw insertion.All the fractured pieces were removed from the surgical site.The procedure was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will capture the second of two screws.
Event or Problem Description
It was reported that 2 yukon polyaxial screws fractured intra-operatively during screw insertion.All the fractured pieces were removed from the surgical site.The procedure was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will capture the second of two screws.
Additional Manufacturer Narrative
The returned yukon oct polyaxial screw was visually inspected.Discoloration was observed on the inside of the tulip head, around the circumference of the anvil component.The screw was confirmed to be fractured at the base of the tulip and the proximal end of the shaft.The fracture surface at the base of the tulip was observed to be relatively even, with little variation in the material surface.The shaft of the screw was determined to be bronze in color, with some discoloration throughout the threading of the device.The fracture surface at the proximal end of the screw shaft was smooth.Heavy deformation of the screw's threading towards the proximal end adjacent to the fracture site was observed.It is suspected this deformation occurred during screw removal from the bone using a separate tool.Complaint history records were reviewed for this catalog, and no similar complaints were identified.The bone was prepared using the drill and line to line tap.The tap used was the same size as the screw being inserted.The screw was firmly attached to a standard driver.The bone quality of the patient was described as hard, as the patient was young.Higher forces may be required to insert a screw due to hard bone quality.When attempting to apply a higher torsional force during insertion, a bending load may have unintentionally been applied to the inserter resulting in the screw fracture.The most likely root cause of the screw fracture during insertion is therefore attributed to patient factors.

• Brand Name: POLYAXIAL SCREW ML; SIZE Ø5.0X30 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: 12857919
• Report Number: 3004774118-2021-00369
• Device Sequence Number: 14451346
• Product Code: NKG
• UDI-Device Identifier: 10888857351851
• UDI-Public: 10888857351851
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• 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,Followup
• Report Date (Section B): 03/09/2022

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: 7601-05030M
• Device Catalogue Number: 7601-05030M
• Device Lot Number: NDTB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/10/2021; 02/09/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/07/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male