MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; EVEREST; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 2901-N90098-B

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Event Description

It was reported that the tip of an everest locking screw inserter became deformed intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

Manufacturer Narrative

The returned everest navigated locking screw inserter was visually inspected.The device appeared cosmetically worn from normal use.The tip was confirmed to be damaged; majority of the hexalobe had fractured off, leaving a relatively even fracture surface.The fracture surface revealed a rotational pattern, indicating the device failed during torsion.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported lot number were identified.The most likely root cause for the tip fracture can be attributed to normal device wear over time, as the instrument has been in the field for approximately 3 years.Consistent use of the instrument throughout its lifetime may cause material fatigue, leading to eventual tip fracture.

Event Description

It was reported that the tip of an everest locking screw inserter became deformed intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.Inspection of the returned device identified tip fracture rather than tip deformation.

• Brand Name: LOCKING SCREW INSERTER; EVEREST
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 14915330
• MDR Text Key: 296077867
• Report Number: 3004774118-2022-00257
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10888857405486
• UDI-Public: 10888857405486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

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
• Device Operator: Health Professional
• Device Model Number: 2901-N90098-B
• Device Catalogue Number: 2901-N90098-B
• Device Lot Number: JCVX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1