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

Catalog Number	5101-90012
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while trying to place a temporary rod in preparation for tlif, an everest mi single action rod reducer tip fractured and became stuck on an everest polayaxial screw at the l5 level.The surgeon was able to get the reducer off of the screw with aggressive force.After tlif, the surgeon tried to reduce the same left l5 screw while attempting to place the final rods.Both basecamp rod reducers popped off of the screw once they were fully reduced.The surgeon then tried to use a denali and an everest mi offset rod reducer, but they also popped off.It was determined that the screw was bent and it was removed and replaced with a new one.Surgery was successfully completed with another reducer and an hour and a half delay.This report represents everest mi offset rod reducer.
Additional Manufacturer Narrative
Visual, functional, material, and dimensional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.It is possible that the reducer tip was damaged.Deformations to the distal clamps could contribute to difficulty during reduction.However, as the device was not available for evaluation, the root cause could not be determined conclusively.
Event or Problem Description
It was reported that while trying to place a temporary rod in preparation for tlif, an everest mi single action rod reducer tip fractured and became stuck on an everest polayaxial screw at the l5 level.The surgeon was able to get the reducer off of the screw with aggressive force.After tlif, the surgeon tried to reduce the same left l5 screw while attempting to place the final rods.Both basecamp rod reducers popped off of the screw once they were fully reduced.The surgeon then tried to use a denali and an everest mi offset rod reducer, but they also popped off.It was determined that the screw was bent and it was removed and replaced with a new one.Surgery was successfully completed with another reducer and an hour and a half delay.This report represents everest mi offset rod reducer.

• Brand Name: MI OFFSET ROD REDUCER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10200164
• Report Number: 3004774118-2020-00128
• Device Sequence Number: 1020061
• Product Code: LXH
• UDI-Device Identifier: 10888857104006
• UDI-Public: 10888857104006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 5101-90012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: Other