MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø8.5X90 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-08590
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest polyaxial screw sheared off below the tulip intra-operatively.There were no adverse consequences to the patient but an unknown surgical delay was reported.
Additional Manufacturer Narrative
Additional information was received and populated in field b5.
Event or Problem Description
It was reported that an everest polyaxial screw sheared off below the tulip intra-operatively.A portion of the broken screw was left in the patient.There were no adverse consequences to the patient but a hour surgical delay was reported.
Additional Manufacturer Narrative
A visual inspection was performed and the screw tulip fracture was confirmed with the fracture site sheered similar to a torsional fracture.Device history records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.The everest degenerative surgical technique - us version was reviewed and the following identified: screw insertion: when using an everest polyaxial screw inserter, grasp the implant by the shaft of the screw and apply a downward force to engage the screw into the hexalobe fitting of the screwdriver shaft.Thread the knurled wheel in a clockwise direction until the implant is securely attached to the inserter.To disengage the screw inserter, gently turn the knurled wheel in a counter-clockwise direction, and remove from the surgical field.Due to the fracture site having a sheared surface and a starting fracture point, it is likely that excessive torsional force was applied to the screw leading to the failure mode.
Event or Problem Description
It was reported that an everest polyaxial screw sheared off below the tulip intra-operatively.A portion of the broken screw was left in the patient.There were no adverse consequences to the patient but a hour surgical delay was reported.

• Brand Name: POLYAXIAL SCREW; SIZE Ø8.5X90 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: 13763303
• Report Number: 3004774118-2022-00103
• Device Sequence Number: 16764490
• Product Code: NKB
• UDI-Device Identifier: 10888857043237
• UDI-Public: 10888857043237
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 06/21/2022

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: 2911-08590
• Device Catalogue Number: 2911-08590
• Device Lot Number: FGGM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 05/23/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2017
• 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