MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X34 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05034
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
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.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 relevant manufacturing issues or similar complaints were identified.According to the complainant¿s follow up responses, the screw hole was not tapped.The surgeon was inserting 5.0 mm screws (the largest of yukon screws), which require more torque.Although the 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 complainant also stated that the patient did not have good bone quality.Inserting the screw in harder than normal bone can compound torsional forces and may have also contributed to the fracture.The surgeon was able to complete the case by removing the broken screws, tapping the screw site, and re-inserting new screws.
Event or Problem Description
This report summarizes one malfunction event where a yukon oct polyaxial screw broke intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X34 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12723258
• Report Number: 3004774118-2021-00337
• Device Sequence Number: 14523593
• Product Code: NKG
• UDI-Device Identifier: 10888857350045
• UDI-Public: 10888857350045
• 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
• Report Date (Section B): 10/29/2021

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: 7601-05034
• Device Catalogue Number: 7601-05034
• Device Lot Number: NTFR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1