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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. LOCKING SCREW INSERTER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 2901-90098
Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 04/20/2020
Event Type  Injury  
Event 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 inserter.
 
Manufacturer Narrative
Visual inspection: the device was inspected and confirmed to have had a screw head stuck on the distal tip.The screw head was firmly stuck onto 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 two components 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.
 
Event 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 inserter.
 
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Brand Name
LOCKING SCREW INSERTER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key10075639
MDR Text Key191598072
Report Number3004774118-2020-00091
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857040564
UDI-Public10888857040564
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2901-90098
Device Lot NumberHRGP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2020
Date Manufacturer Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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