MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X28 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05028
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Stryker representative reported that the head of a yukon oct spinal system polyaxial screw; size ø5.0x28 mm broke off when the screwdriver detached from the tulip head intra-operatively.The procedure was successfully completed with a 5 minute surgical delay.
Event or Problem Description
Stryker representative reported that the head of a yukon oct spinal system polyaxial screw; size ø5.0x28 mm broke off when the screwdriver detached from the tulip head intra-operatively.The procedure was successfully completed with a 5 minute surgical delay.
Additional Manufacturer Narrative
Correction to d.3.: updated from 'stryker spine- us' to 'k2m, inc.' additional information: d.4.Lot #.
Event or Problem Description
Stryker representative reported that the head of a yukon oct spinal system polyaxial screw broke off when the screwdriver detached from the tulip head intra-operatively.The procedure was successfully completed with a 5 minute surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the screw tulip and the screw head ball was fractured from the screw shank.The fracture surface was seen to be smooth, indicating a brittle fracture.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: screw insertion.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.The subject screws have a diameter of 05.0x28 mm which require more torque.Excessive manipulation and off-axis forces may have overloaded the screw housing assemblies, resulting in the failure.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X28 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9963817
• Report Number: 3004774118-2020-00073
• Device Sequence Number: 11448249
• Product Code: NKG
• UDI-Device Identifier: 10888857350014
• UDI-Public: 10888857350014
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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: 7601-05028
• Device Catalogue Number: 7601-05028
• Device Lot Number: JKAN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 04/27/2020; 06/30/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/22/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR