MAUDE Adverse Event Report: K2M, INC. MI ROD REDUCER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90179
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside the or the tip of an everest mi rod reducer was discovered to be broken.No adverse consequences, surgical delay, or medical intervention were reported.The procedure was completed successfully.
Additional Manufacturer Narrative
A visual inspection was performed and discoloration was observed on the gold tabs, and unknown residue substance was seen on the inside of the reduction tunnel.One of the gold tabs was protruding from the device slightly more than the other.The portion of the gold tabs that assembles with the screw tulip were seen to be deformed from use.The device was functionally inspected by attempting to assemble with an everest screw and fully engage the tunnel to the reduced position.The device was able to engage and disengage the screw using excessive force.It is suspected that the gold tabs are jammed in the tulip head once assembled.The device was able to retract into the fully reduced state by rotating the proximal end.Due to excessive force required to assemble and disassemble the device from the screw, the device does not function as intended.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history was reviewed and no previous complaints for this lot were found.The everest mi xt surgical technique was reviewed.Use of the related device is detailed in the everest mi xt surgical technique which details to seat the recovery alignment tool into the screw head and slide the recovery reduction tunnel over the recovery alignment tool until it is attached to the screw head.Rotate the proximal knob clockwise to begin reduction.Tighten or loosen positions are selected by adjusting the rotation knob into forward, neutral, or reverse.The root cause of the reported event can be attributed to customer use of the instrument.Complex maneuvers, difficult angles, and excessive force used on the device by the user could have contributed to the reported failure mode.
Event or Problem Description
It was reported that outside the or the tip of an everest mi rod reducer was discovered to be broken.No adverse consequences, surgical delay, or medical intervention were reported.The procedure was completed successfully.

• Brand Name: MI ROD REDUCER
• 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: 12527060
• Report Number: 3004774118-2021-00289
• Device Sequence Number: 4428036
• Product Code: LXH
• UDI-Device Identifier: 10888857279438
• UDI-Public: 10888857279438
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 5101-90179
• Device Lot Number: NBHE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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