MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Two (2) of the two (2) devices have been returned for analysis: lot 2362: received 08/jul/2021, lot nxrf: received 22/jul/2021.A supplemental vmsr will be submitted upon completion of the investigations.
Event or Problem Description
This report summarizes two malfunction events where yukon oct polyaxial screws fractured intra-operatively.Surgeries were successfully completed with a 15 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Lot# 2362 - visual inspection: it was observed that the screw had fractured immediately below the ball feature of the screw shank.Analysis of the fracture face suggests that the failure occurred in torsion.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It is possible that insufficient screw site preparation contributed to the failure.According to the rep, an everest thoracic probe was used to make the screw pathway.However, the surgeon was inserting a 5.0 mm screw (the largest of yukon screws), which require more torque.Although yukon screws are self-tapping, taps are included in the set to significantly decrease the amount of insertion torque required to insert the screw.Alternatively, the surgeon can use a larger diameter drill for the pilot hole.The broken screw was removed and replaced, and the surgery was completed.Lot# nxrf - visual inspection: it was observed that the screw had fractured on the shank, below the tulip head.Complaint history was reviewed for the reported lot and no similar complaints were identified.Upon correspondence with the rep, it was suggested that a 3.0 tap size was used for screw site prep.Under sizing the tap by 2.0 mm likely created excessive torsional load during insertion, contributing to the observed fracture.
Event or Problem Description
This report summarizes two malfunction events where yukon oct polyaxial screws fractured intra-operatively.Surgeries were successfully completed with a 15 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12247668
• Report Number: 3004774118-2021-00231
• Device Sequence Number: 11872239
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 2
• 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): 10/27/2021

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: 7601-05030
• Device Catalogue Number: 7601-05030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1