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

Catalog Number	1001-90166
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reported that towards the end of a case and while disengaging the reducer; the denali mi spinal system mi offset rod reducer distal tip fractured intra-operatively.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
D.4.Lot number has been corrected from 'gdcn' to 'dgcn'.Visual inspection: the device was inspected, and the tip fracture was confirmed.Functional inspection: when reducing the instrument, difficulty was observed.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: rod reduction.Reducing the rod into the screw saddles can be accomplished by using a variety of instruments including the single action anti-torque rod reducer (praying mantis¿) and mi offset reducer (yellow jacket¿).Remove the gelpi retractors and position the reduction instrument into the serengeti retractor.Apply a downward force to engage the instrument to the screw head.Tip: for fast action reduction of the yellow jacket, pull the pistol style handle until the rod is fully reduced, then place a set screw down the cannulated shaft while still holding the handle.For controlled reduction, turn the proximal knob until the rod is fully reduced, then place a set screw down the cannulated shaft.To assist engaging the praying mantis onto the screw head, gently toggle the instrument back and forth until a ¿click¿ is heard on each side.The most likely cause of the reported event was determined to be normal wear.As the instrument was manufactured in 2014 and is over six years old, repeated use over the service life of the instrument may have compromised the functionality of the device, causing the observed difficulty and subsequent fracture.
Event or Problem Description
The surgeon reported that towards the end of a case and while disengaging the reducer; the denali mi spinal system mi offset rod reducer distal tip fractured intra-operatively.No adverse consequences or medical intervention were reported.

• 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: 10901012
• Report Number: 3004774118-2020-00325
• Device Sequence Number: 2542971
• Product Code: LXH
• UDI-Device Identifier: 10888857001251
• UDI-Public: 10888857001251
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/25/2021

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: 1001-90166
• Device Lot Number: DGCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 01/30/2021
• Initial Report FDA Received Date: 11/25/2020
• 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