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

Catalog Number	6201-90084
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of a mesa 2 reduction jack cricket fractured intra-operatively.It was later noted that the fractured component had been left inside the patient and revision surgery to remove the tip has occurred.
Additional Manufacturer Narrative
Visual, functional, material and dimensional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Crickets are a valuable aid in reduction/correction maneuvers in complex degenerative surgeries, but are occasionally stressed beyond their structural capacity.Crickets were designed such that the significant loads encountered in complex spine surgeries are not transferred to the screw interface.Additional reduction jacks are made available in each set so that the delay in surgery time is minimal and there is no adverse effect to the patient.No further investigation for this event is possible at this time as no device was received.If device and / or additional information becomes available, this investigation will be reopened.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that the tip of a mesa 2 reduction jack cricket fractured intra-operatively.It was later noted that the fractured component had been left inside the patient and revision surgery to remove the tip has occurred.

• 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
• MDR Report Key: 10766496
• Report Number: 3004774118-2020-00293
• Device Sequence Number: 3840918
• Product Code: LXH
• UDI-Device Identifier: 10888857320468
• UDI-Public: 10888857320468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6201-90084
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention