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

Model Number	602-90780
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the knob of an aleutian an inserter fractured off from the shaft intra-operatively.Surgery was successfully completed and no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that the knob of an aleutian an inserter fractured off from the shaft intra-operatively.Surgery was successfully completed and no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed on the device and the reported issue of fracture of the proximal knob was confirmed.The inner shaft was able to be taken out.Device history records were not reviewed for the corresponding lot so no relevant issues were identified.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.It was initially reported that the top of the aleutian an inserter inner shaft sheared off during impaction.Cascadia an view and guide surgical technique was reviewed: ¿the proximal end of the implant should be aligned with the distal tip of the inserter so the fingers on the inserter line interbody insertion up with the recesses on the implant and the angled surfaces of the implant and inserter align.The implant can then be threaded onto the inserter by turning the thumbwheel at the proximal end of the inner shaft clockwise." the damage on the returned device evidenced knob fracture on the proximal end of the inserter.The most likely case for this failure mode based on the deformation observed is excessive torsional force.As the customer reported that the inserter fractured when malleating this is most likely because the inserter was at the yielding point from the torsional force applied with the mallet causing it to go over that threshold and fracture.

• Brand Name: AN 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: 13979860
• Report Number: 3004774118-2022-00127
• Device Sequence Number: 5568222
• Product Code: MAX
• UDI-Device Identifier: 10888857157255
• UDI-Public: 10888857157255
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160547
• 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): 07/05/2022

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: 602-90780
• Device Catalogue Number: 602-90780
• Device Lot Number: NHKJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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