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

Catalog Number	1001-90166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
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 the denali offset rod reducer.
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 the denali offset rod reducer.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and no deformities or abnormalities were observed.Functional inspection: the instrument was tested with both a sample screw and the screw that was used in surgery.The instrument was able to reduce a sample rod in both screws as intended.To remove the reducer, a twisting motion was applied.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.It is possible the instrument may have been unintentionally twisted fully or partially, allowing the reducer to disengage prematurely from the screw.However, as certain maneuvers applied during actual surgery could not be replicated during functional testing, the root cause could not be determined conclusively.

• Brand Name: MI OFFSET ROD REDUCER; YELLOW JACKET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10202323
• Report Number: 3004774118-2020-00129
• Device Sequence Number: 19087698
• Product Code: LXH
• UDI-Device Identifier: 10888857001251
• UDI-Public: 10888857001251
• 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): 08/19/2020

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: 1001-90166
• Device Lot Number: BJTM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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