MAUDE Adverse Event Report: K2M, INC. TLIF II ADJUST.TORQUE LIMITING, INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	3303-90384
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cage placement two aleutian torque limiting shafts and adjustable inserters disengaged from the implant causing incorrect placement of the implant.The inner shaft was then reinserted to reposition the cage, however, now the surgeon could no longer release the cage from the inserter.This record captures the first torque limiting inner shaft.
Additional Manufacturer Narrative
A visual inspection was performed there were marks from tamping on the distal end where the securing mechanism is located.The knob on the inner shaft was also observed to be loose which was likely caused by tamping the inner shaft.Functional inspection was performed, when paired with a functional inserter the inner shaft was able to position the sample implant, secure it, and release it.The securing mechanism on the inner shaft was loose which can be assumed was a result of tamping based on the marks.When paired with another inserter that had a damaged tip the implant wasn't able to be positioned properly.The event of the securing mechanism jamming was not able to be replicated.Complaint history records were reviewed for this catalog, no adverse trends were identified.Additional attempts were made to obtain more information, but no additional correspondence was received.The aleutian tlif ii surgical technique was reviewed and the following relevant information was identified: 'implant insertion (cont.) the proximal end of the implant is threaded onto the stud at the distal end of the inserter, taking care to ensure the recess in the implant is aligned with the finger on the inserter by turning the thumbwheel at the proximal end of the inner shaft.The thumbwheel contains a torque limiting mechanism which is designed to skip when the implant is secured to the inserter.The implant should tangentially touch the inserter.Following implant attachment, the inner shaft should be removed from the inserter'.Since this event was unable to be replicated for the reported failure mode with the instrument during functional analysis, a conclusive cause could not be determined.Based on the surgical technique the aleutian tlif ii surgical techniques state that the inner shaft should be removed prior to malleting the inserter.
Event or Problem Description
It was reported that during cage placement two aleutian torque limiting shafts and adjustable inserters disengaged from the implant causing incorrect placement of the implant.The inner shaft was then reinserted to reposition the cage, however, now the surgeon could no longer release the cage from the inserter.This record captures the first torque limiting inner shaft.

• Brand Name: TLIF II ADJUST.TORQUE LIMITING, INNER SHAFT
• 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: 13529347
• Report Number: 3004774118-2022-00058
• Device Sequence Number: 4039728
• Product Code: MAX
• UDI-Device Identifier: 10888857078895
• UDI-Public: 10888857078895
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150481
• 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): 05/16/2022

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: 3303-90384
• Device Catalogue Number: 3303-90384
• Device Lot Number: BTND120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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