MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø4.0X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04024
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative yukon polyaxial screw fracture.The procedure was completed successfully with an unspecified surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot 24em (1): was returned 07 april 2022.The investigation is still in process; we will communicate our findings in a follow-up report.
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative yukon polyaxial screw fracture.The procedure was completed successfully with an unspecified surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot 24em (1): the returned device was analyzed for macroscopic indications of failure mode.Fracture occurred immediately above the threaded region.No significant plastic deformation was observed.The crack appears to have initiated from the region immediately adjacent to the root of the first thread.The screw appears to have broken at a shallow angle with respect to the shaft axis; this can be a characteristic of brittle failure under torsion and compression.These are forces the screw would have been subjected to during insertion.A thin shear lip characteristic of brittle fracture was observed around the edge of the final failure region.On the tulip side of the fracture, the recessed region indicates the probable fracture initiation site and the raised region indicates the location of final failure.Conversely, on the threaded side of the fracture, the raised region of the fracture surface indicates the probable initiation site while the recessed region indicates the location of final failure.Significant abrasions and mechanical damage were observed on both the male and female regions of the threads near the neck of the screw.A section of the threading beginning at the root of the first thread was plastically deformed upward toward the tulip.Complaint history for the reported lot number was reviewed and no adverse trends were identified.The most likely root cause was brittle overload from combined compressive and torsional forces.In brittle overload, the crack begins at the point of maximum stress, grows across the cross section, and fractures.This failure appears to have originated from the root of the first screw thread at the transition point between the threads and the screw head.This portion of the screw can be particularly susceptible to fracture under considerable stress.Attempts to correct the implanted screw's positioning may have exerted excessive stress on the implant, leading to fracture.

• Brand Name: POLYAXIAL SCREW; SIZE Ø4.0X24 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: 14253129
• Report Number: 3004774118-2022-00161
• Device Sequence Number: 17183351
• Product Code: NKG
• UDI-Device Identifier: 10888857349575
• UDI-Public: 10888857349575
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 7601-04024
• Device Catalogue Number: 7601-04024
• Device Lot Number: 24EM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/27/2022
• 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: Unknown