MAUDE Adverse Event Report: K2M, INC. AN MI INSERTER INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	602-90449
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection: the inner shaft was returned with the knob fractured off of it.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.From aleutian an surgical technique guide: insertion option 2 - an mi inserter - insert the inner shaft through the proximal end of the inserter and rotate clockwise 1¿2 turns to engage the threads.Attach the implant to the distal end of the inserter.Final tighten the implant by turning the knob of the inner shaft on the proximal end of the inserter.The an slotted mallet may be used to aid in implant placement.X-ray or fluoroscopy may be used live or periodically to verify placement.After the implant is properly seated in the disc space, turn the inner shaft knob at the proximal end of the inserter to disengage the implant.In the event the implant must be removed, the an inserter can be reattached and the implant subsequently extracted.Care must be taken to protect the neural elements when removing the an inserter and an mi inserter from the surgical site.The an inserter can then be removed.For fine adjustments of the implant or countersinking, the an pusher may be utilized, if necessary.It was reported that the force used was greater than normal.The stg confirms that the an slotted mallet may be used to aid in implant placement.The most likely cause is excessive force with the mallet against the inner shaft caused the knob to fracture off.
Event or Problem Description
It was reported that the knobs of two aleutian an mi inserter inner shafts fell off after being struck with a hammer intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.This report will capture the second of 2 shafts.

• Brand Name: AN MI INSERTER 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: 13760671
• Report Number: 3004774118-2022-00101
• Device Sequence Number: 17627966
• Product Code: MAX
• UDI-Device Identifier: 10888857117556
• UDI-Public: 10888857117556
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/14/2022

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: 602-90449
• Device Catalogue Number: 602-90449
• Device Lot Number: MAJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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