MAUDE Adverse Event Report: K2M, INC. REDUCTION JACK; CRICKET 2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6201-90084
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes three malfunction events where the feet of mesa 2 reduction jack crickets fractured intra-operatively.Surgeries were successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: lot harn ((b)(4) devices) received 29/oct/2021; manufactured 25/jun/2018.Lot fenf received 21/oct/2021; manufactured 22/dec/2016.Visual inspection: the feet of the crickets was found to be fractured.Deformation was found on the threads, causing the device to jam.Deformation was found on every other thread, indicating that the cricket was not fully inserted into the screw head.When the cricket is not properly seated, this can cause loading on a single thread while the user attempts to force the screw jack down, causing deformation of the threads.Functional inspection: confirmed crickets were jammed.Device and complaint history records were reviewed for these lots, and no relevant manufacturing issues or similar complaints were identified.Based on the deformation found on the screw threads, the likely cause is misalignment of the cricket feet with the screw during reduction, causing the threads to deform and jam.Misalignment of the foot and the likely excessive force applied due to the device jamming likely caused the feet to fracture.

• Brand Name: REDUCTION JACK; CRICKET 2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 13361956
• Report Number: 3004774118-2022-00032
• Device Sequence Number: 5010937
• Product Code: LXH
• UDI-Device Identifier: 10888857320468
• UDI-Public: 10888857320468
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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 Catalogue Number: 6201-90084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2022
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown