MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE Ø4.0X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04024M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event where during insertion, the shaft of a yukon screw broke.It was further reported that the distal portion was not able to be removed from the bone.Surgery was successfully completed with a 3 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.A supplemental vmsr will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual inspection: the device was inspected, and 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.Complaint history records were reviewed for this catalog and no similar complaints were identified.According to the follow up responses, the surgeon believes that the resident was not inserting the screw co-linear and may have been putting pressure on the lateral side.Additionally, it was reported that the patient's bone quality was very hard.Inserting the screw in harder than normal bone can compound torsional forces, resulting in fracture.The distal portion of the screw remains in the patient.
Event or Problem Description
This report summarizes one malfunction event where during insertion, the shaft of a yukon screw broke.It was further reported that the the distal portion was not able to be removed from the bone.Surgery was successfully completed with a 3 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW ML; SIZE Ø4.0X24 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12720859
• Report Number: 3004774118-2021-00329
• Device Sequence Number: 1364105
• Product Code: NKG
• UDI-Device Identifier: 10888857350410
• UDI-Public: 10888857350410
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• 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): 01/25/2022

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: 7601-04024M
• Device Catalogue Number: 7601-04024M
• Device Lot Number: MXJG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/01/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown