MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 8.5X55 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-08555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	04/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an everest locking screw inserter jammed and an everest polyaxial screw fractured intra-operatively.When the surgeon attempted to remove the screw, the screw head popped off and was stuck on the instrument.There was no surgical delay, however the procedure was not completed successfully as the rod was not able to be connected at the desired level and the screw shaft remained in the patient.This report represents the screw.
Event or Problem Description
It was reported that an everest locking screw inserter jammed and an everest polyaxial screw fractured intra-operatively.When the surgeon attempted to remove the screw, the screw head popped off and was stuck on the instrument.There was no surgical delay, however the procedure was not completed successfully as the rod was not able to be connected at the desired level and the screw shaft remained in the patient.This report represents the screw.
Additional Manufacturer Narrative
Visual inspection: the returned device was inspected and found to have been a fractured off screw head.The fractured off screw head was confirmed to have been stuck on the distal tip of the instrument.The screw head was firmly stuck to the threads of the inserter and was unable to be removed.It was found that the threads which connect to the screw head were damaged which suggests that sufficient force was applied to cause thread deformation.Thread deformation due to excessive force could have caused the implant and instrument to bind together.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified as all units met stryker specifications.Everest deformity surgical technique was reviewed and the following relevant information was identified: after the pedicle pathway has been prepared and proper screw length and diameter have been determined, the appropriate implant is selected and loaded for screw insertion using the everest deformity screw inserter.The everest deformity screw inserter will work with both polyaxial and uniplanar everest screws.To load the everest deformity 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 screw inserter shaft.Thread the silver knob in a clockwise direction until the implant is securely attached to the inserter.Pull the silver knob toward the handle to lock the inserter onto the screw.To disengage the screw inserter, pull down on the silver knob, gently turn in a counter-clockwise direction, and remove the inserter from the surgical field.Thread deformation due to excessive force could have caused the two components to bind together.It appears that instrument misuse contributed to the issue as the event was reported to have occurred during screw removal.As a result, it appears that the root cause of the issue was instrument misuse as the locking screw inserter was used to remove a screw.

• Brand Name: POLYAXIAL SCREW; SIZE 8.5X55 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10075403
• Report Number: 3004774118-2020-00090
• Device Sequence Number: 2783221
• Product Code: NKB
• UDI-Device Identifier: 10888857043091
• UDI-Public: 10888857043091
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2911-08555
• Device Catalogue Number: 2911-08555
• Device Lot Number: GWCK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other