MAUDE Adverse Event Report: K2M, INC. FOUNDATION SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06540D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner collet of a mesa spinal system foundation screw; size ø6.5x40 mm at l2 broke intra-operatively.The screw was replaced and surgery was successfully completed after a 5 minute delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that the inner collet of a mesa spinal system foundation screw; size ø6.5x40 mm at l2 broke intra-operatively.The screw was replaced and surgery was successfully completed after a 5 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the device was inspected and confirmed to have had a fractured inner collet.One of the two tabs fractured and appeared to be consistent with a brittle fracture failure.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.The fracture most likely occurred due to the application of excessive force during the rail bending maneuver.Inner collets can be damaged/broken if they are subjected to an excessive amount of force during installation of the construct.The most likely root cause for the issue was determined to have been excessive force applied during rail bending.

• Brand Name: FOUNDATION SCREW; SIZE 6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10246496
• Report Number: 3004774118-2020-00137
• Device Sequence Number: 548121
• Product Code: NKB
• UDI-Device Identifier: 10888857136120
• UDI-Public: 10888857136120
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: 801-06540D
• Device Catalogue Number: 801-06540D
• Device Lot Number: JJNG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1