MAUDE Adverse Event Report: K2M, INC. THORACIC PROBE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	101-90054
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a denali spinal system thoracic probe fractured intra-operatively.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Corrected data: d.4.Lot number updated from 'k2m agtj' to 'agtj'.Visual inspection: device was inspected and found to have a fractured distal tip between the 30 mm and 40 mm markings.Little to no plastic deformation was detected indicating brittle fracture had occurred.Fracture surface was angled and uneven and likely occurred due to excessive bending stress.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: the desired entry point of the pedicle is chosen and then perforated with an awl to expose the underlying cancellous bone.The entry point is then cannulated with the small pedicle probe.The small pedicle probe is advanced to the appropriate depth, as determined by the surgeon.The correct insertion of the instrument will allow the tip of the probe to follow a path of least resistance, reducing the potential of perforating the pedicle walls.The small pedicle probe is laser etched at 10 mm increments from 10-50 mm, indicating the depth to which the probe has been inserted.These markings also help the surgeon assess proper drill and screw length.Little to no plastic deformation was detected indicating brittle fracture had occurred.Fracture surface was angled and uneven and likely occurred due to excessive bending stress.It was observed from the device history record review that the instrument was ~10 years old.Factors such as consistent use of the instrument and multiple re-processing cycle throughout its lifetime can contribute to fatigue on the instrument, leading to the reported fracture.
Event or Problem Description
It was reported that a denali spinal system thoracic probe fractured intra-operatively.No adverse consequences to the patient were reported.

• Brand Name: THORACIC PROBE
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9777281
• Report Number: 3004774118-2020-00023
• Device Sequence Number: 19415902
• Product Code: LXH
• UDI-Device Identifier: 10888857009868
• UDI-Public: 10888857009868
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 06/15/2020

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 Catalogue Number: 101-90054
• Device Lot Number: AGTJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1