MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-04030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implant insertion, the yukon polyaxial screw head "sheared completely off" where it meets the tulip.2/3 of the screw shank remained in the patient.An attempt to remove the screw resulted in a 20 minute delay.No adverse consequences to the patient.The patient is reported to be "doing well." the surgeon was able to obtain good fixation and the surgery was completed successfully.
Event or Problem Description
It was reported that during implant insertion, the yukon polyaxial screw head "sheared completely off" where it meets the tulip.2/3 of the screw shank remained in the patient.An attempt to remove the screw resulted in a 20 minute delay.No adverse consequences to the patient.The patient is reported to be "doing well." the surgeon was able to obtain good fixation and the surgery was completed successfully.
Additional Manufacturer Narrative
Correction: updated from 'stryker spine (b)(6) to 'k2m, inc.' visual inspection: the device was inspected, and it was observed that the screw head assembly with proximal ball feature had separated from the screw shank.The fracture occurs immediately distal to the proximal ball feature of the screw shank.Analysis of the fracture face suggests the failure occurred in torsion.A review of the device history was performed and there were no relevant manufacturing issues identified as all units met stryker specifications.A review of the complaint history records was performed and there were no similar complaints identified.Per surgical technique: 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.Analysis of the fracture face suggests the failure occurred in torsion.According to the rep, the patient had very hard bone, and the screw head assembly and proximal ball feature of the screw fractured during implant insertion.The most likely cause of the reported event was determined to be the patient's bone quality.It is possible excessive force was applied to insert the screw in harder than normal bone, resulting in failure.

• Brand Name: POLYAXIAL SCREW; SIZE 4.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8857067
• Report Number: 3004774118-2019-00074
• Device Sequence Number: 221517
• Product Code: NKG
• UDI-Device Identifier: 10888857349605
• UDI-Public: 10888857349605
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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 Catalogue Number: 7601-04030
• Device Lot Number: JAVW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 12/01/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1