MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05024
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A stryker sales representative identified an incorrectly marked yukon polyaxial screw during restock of a consignment set tray, outside the operating theater.The subject screw was incorrectly laser marked with size ø5.0 (diameter) & 24 (mm length) with catalog number 7601-05024.However, the screw should have been marked ø4.0 (diameter) & 26 (mm length) with associated catalog number 7601-04026.There was no associated procedure and therefore no adverse consequence to a patient.
Additional Manufacturer Narrative
Visual inspection of the device confirmed that the screw was incorrectly laser marked as 5.0 x 24 mm when it was actually measured 4.0 x 26 mm.The part was physically conforming to the drawing specification; however, the catalog number, diameter, and length were incorrectly laser marked.A non-conformance was initiated to investigate the root cause associated with this event.Stryker initiated a field safety corrective action on 14 december 2020 and notification was sent to the impacted customers.Affected items will be retrieved at the customer's sites and will be destroyed upon return to stryker distribution sites.
Event or Problem Description
A stryker sales representative identified an incorrectly marked yukon polyaxial screw during restock of a consignment set tray, outside the operating theater.The subject screw was incorrectly laser marked with size ø5.0 (diameter) & 24 (mm length) with catalog number 7601-05024.However, the screw should have been marked ø4.0 (diameter) & 26 (mm length) with associated catalog number 7601-04026.There was no associated procedure and therefore no adverse consequence to a patient.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X24 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10969239
• Report Number: 3004774118-2020-00340
• Device Sequence Number: 11397635
• Product Code: NKG
• UDI-Device Identifier: 10888857349995
• UDI-Public: 10888857349995
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 7601-05024
• Device Catalogue Number: 7601-05024
• Device Lot Number: KRBX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 87075
• Patient Sequence Number: 1