MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported that while performing a c1-t1 fusion, the head broke off of a yukon oct spinal system polyaxial screw; size 05.0x26mm in the left t1 intra-operatively.There was no adverse consequence to the patient.Surgery was completed with a 15 minute delay and a new screw of the same size.
Additional Manufacturer Narrative
During visual inspection, it was observed that the screw head was separated from the screw shank.Abrasions can be observed on the screw threads.Device history records were reviewed and no relevant manufacturing complaints were identified.Complaint history records were reviewed and one similar complaint was found.Per surgical technique: after the pedicle pathway has been prepared and proper screw size has been determined, load the implant for screw insertion using a yukon screw inserter.When loading the yukon screws, grasp the implant by the screw shaft and give a slight rotation, while simultaneously applying a downward force to properly engage the screw.Once loaded, spin the knob located above the sleeve clockwise to lock the screw in place.The yukon screw inserter has a black sleeve for ease of identification.Once the screw has been loaded, insert it into the pilot hole until desired depth is reached.Disengage the screw inserter by turning the knob above the sleeve counter-clockwise.Repeat until all screws are placed.Note: the yukon screw inserter can be used with either the ratcheting axial handle or the fixed axial handle.The screw was broken at the transition between the head and shaft.Analysis of the fracture face indicates that the failure could have occurred in torsional overload.The subject screws has a diameter of 05.0x26 mm, which require more torque.Excessive manipulation and off-axis forces may have overloaded the screw housing assemblies could result in the reported failure.
Event or Problem Description
Physician reported that while performing a c1-t1 fusion, the head broke off of a yukon oct spinal system polyaxial screw; size 05.0x26mm in the left t1 intra-operatively.There was no adverse consequence to the patient.Surgery was completed with a 15 minute delay and a new screw of the same size.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X26 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9298343
• Report Number: 3004774118-2019-00140
• Device Sequence Number: 16729580
• Product Code: NKG
• UDI-Device Identifier: 10888857350007
• UDI-Public: 10888857350007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 7601-05026
• Device Catalogue Number: 7601-05026
• Device Lot Number: GGXE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR