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

Catalog Number	6201-90085
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
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual inspection: the tip of the device was observed to be fractured and the device threads were found to be jammed.Functional inspection: device was found to be jammed.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The field representative reported that a power driver was used during reduction and that excessive torque may have been used to correct the scoliosis patient.According to the mesa surgical technique, the crickets are to be tightened using the size 25 screwdriver shaft and a handle; not a power drill.The cricket likely jammed due to excessive force that was used during reduction using the power drill.Additionally, reduction maneuvers associated with complex deformity surgeries may focus increased loading to the reduction jack cricket.
Event or Problem Description
This report summarizes one malfunction event where the tip of a mesa 2 reduction jack cricket "broke" intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: REDUCTION JACK RAIL; 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: 13361899
• Report Number: 3004774118-2022-00031
• Device Sequence Number: 3679978
• Product Code: LXH
• UDI-Device Identifier: 10888857323698
• UDI-Public: 10888857323698
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 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: 6201-90085
• Device Lot Number: GBKM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 09/29/2017
• 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