MAUDE Adverse Event Report: K2M, INC. SACROILIAC SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø10.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	E5111-01040
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that when an everest xt fenestrated extended tab sacroiliac screw got stuck 2/3 of the way in s1, the screw tabs fractured intra-operatively.Surgery was successfully completed with a 30 to 40 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records were reviewed for this catalog, and no relevant manufacturing issues or similar complaints were identified.Additional communication provided that an audible ¿crunching¿ of the bone was heard during screw insertion.The screw stopped advancing about 2/3rds of the way into the bone.The screw was left inserted, sticking out from the patient¿s bone.The audible sound during initial insertion may indicate the patient had sclerotic bone, or bone cement residue from the previous implant.This would require higher forces needed to insert the screw into the pedicle.The most likely root cause of the screw's inability to be fully inserted into the pedicle is due to the patient's bone quality and previous implantations, however this cannot be conclusively determined.
Event or Problem Description
It was reported that when an everest xt fenestrated extended tab sacroiliac screw got stuck 2/3 of the way in s1, the screw tabs fractured intra-operatively.Surgery was successfully completed with a 30 to 40 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: SACROILIAC SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø10.5X40 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: 12800779
• Report Number: 3004774118-2021-00352
• Device Sequence Number: 12156475
• Product Code: NKB
• UDI-Device Identifier: 10888857229174
• UDI-Public: 10888857229174
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151727
• 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
• Report Date (Section B): 02/18/2022

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: E5111-01040
• Device Catalogue Number: E5111-01040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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