MAUDE Adverse Event Report: K2M, INC. LORDOTIC TRIAL; SIZE 28X36X17 MM, 15°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	702-90178
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an anterior lumbar disc prep lordotic trial became stuck on and inserter and inner shaft during intra-operative trialing.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Once the trial was removed from the inserter, the trial was inspected and no issues were found with it.There was no visible deformation to the threading.The inner shaft was also returned, it was inserted into the main inserter with a trial attached and was confirmed to be jammed.The device was able to be unjammed with much force applied in a vice.Once the trial was freed, a test inserter was used and was able to be easily threaded and unthreaded onto the trial.The trial functioned as expected after being unjammed from the returned inserter.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The inserter inner shaft was investigated in another record.After the device was unjammed, it was found that the distal threads were deformed.Cosmetic damage was found on the handle and impact marks from tamping were also found.No issues were found with the inserter.Based on the damage found on the inner shaft, excessive force from malleting could have caused damage to the threads, causing the inner shaft to cross thread with the trial, causing the jam.It is also possible the inner shaft was not properly aligned with the trial before threading and the device was cross threaded and caused damage to the threads.No issues were found with the trial after becoming unjammed and the trial functioned as expected with an undamaged inner shaft.
Event or Problem Description
It was reported that an anterior lumbar disc prep lordotic trial became stuck on an inserter and inner shaft during intra-operative trailing.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: LORDOTIC TRIAL; SIZE 28X36X17 MM, 15°
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 13446893
• Report Number: 3004774118-2022-00041
• Device Sequence Number: 20199246
• Product Code: MAX
• UDI-Device Identifier: 10888857128002
• UDI-Public: 10888857128002
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133614
• 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): 06/10/2022

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 Model Number: 702-90178
• Device Catalogue Number: 702-90178
• Device Lot Number: KBXN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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