MAUDE Adverse Event Report: K2M, INC. INSERTER THREADED SHAFT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2112-90009
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of device is unknown.
Event or Problem Description
It was reported that a capri inserter threaded shaft became deformed intra-operatively.The surgeon hit the device several times with a metal mallet during cage insertion and could not remove the driver.The device was removed by hammering the t-handle into the shaft.Surgery was successfully completed in the with a 10 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: it was observed that the proximal female hexalobe feature was deformed.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: cage insertion.With the desired cage selected and assembled, pass the inserter threaded shaft down the inserter.Use the short size 20 non-tapered driver to thread the inserter onto the cage at the insertion point for the desired approach and introduce the cage into the site.According to the rep, the inserter was hit with a metal mallet several times in order to push the cage into the vertebral space.When it came time to remove the inner shaft, the proximal end had been deformed by the mallet and the driver could not be removed.Per the surgical technique, the curved or angled pusher should be used to assist in positioning the cage.The most likely cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that a capri inserter threaded shaft became deformed intra-operatively.The surgeon hit the device several times with a metal mallet during cage insertion and could not remove the driver.The device was removed by hammering the t-handle into the shaft.Surgery was successfully completed with a 10 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: INSERTER THREADED SHAFT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10804584
• Report Number: 3004774118-2020-00295
• Device Sequence Number: 3760581
• Product Code: MQP
• UDI-Device Identifier: 10888857033665
• UDI-Public: 10888857033665
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142016
• 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): 01/11/2021

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 Model Number: 2112-90009
• Device Catalogue Number: 2112-90009
• Device Lot Number: JTMU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1