MAUDE Adverse Event Report: K2M, INC. HEIGHT EXPANSION DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2112-90007
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the capri height expansion driver no longer, "locks securely and adequately to the screw plug," intra-operatively.Surgery was successfully completed with the device, and a 10 minute delay.No adverse consequences, or medical intervention were reported.
Event or Problem Description
It was reported that the capri height expansion driver no longer "locks securely and adequately to the screw plug' intra-operatively.Surgery was successfully completed with the device and a 10 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
The device was visually inspected, and it was observed that the driver teeth at the distal tip exhibited signs of damage.Complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: to expand the capri large expandable corpectomy cage, pass the height expansion driver¿connected to the grey 12 in-lbs torque limiting handle¿down the cannulated shaft of the inserter.Turn the driver clockwise to expand the height of the cage.When the cage has reached its maximum expansion point, stop pins will engage to prevent the cage from over expanding.The deformation to the driver tip is consistent with the effects of over-torqueing.However, it was reported that the 12 inch/pound torque limiting handle was used with the expansion driver as indicated in the ifu.The cause of the reported incident could not be determined conclusively.

• Brand Name: HEIGHT EXPANSION DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10759542
• Report Number: 3004774118-2020-00290
• Device Sequence Number: 3840915
• Product Code: LXH
• UDI-Device Identifier: 10888857033641
• UDI-Public: 10888857033641
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 2112-90007
• Device Catalogue Number: 2112-90007
• Device Lot Number: KHJW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1