MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE 5.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-05535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner collet of 3 mesa sm stature deformity polyaxial screws broke during reduction of the rail intra-operatively.The screws were removed and replaced.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will represent the second of three screws.
Additional Manufacturer Narrative
Visual inspection: upon inspection of the returned device, the inner collet was confirmed to be fractured.Off axis indentations were seen on the tab/lip of the inner collet from reduction instrument.Device and complaint history records were reviewed, and one similar complaint was identified.Per surgical technique: partially lock the proximal fixation points using the rail reduction jack partial locker, also known as the rail superfly, over the rail crickets.It is important the rail crickets are fully reduced for the rail superfly to be properly docked.Introduce the rail superfly over the rail cricket and squeeze the handle to the shaft.Reduce the remaining rail crickets at least halfway at apical levels and tighten so they "kiss" the mesa rail at all other levels.Note: because of the unique geometry, the mesa rail provides significant axial correction by simply tightening the rail deformity crickets slowly along the construct.Be sure to distribute the forces along the entire construct to avoid point-loading the bone-screw interface.Upon inspection of the returned device, one side of the inner collet was confirmed to be fractured.Off-axial indentations were seen on the tab/lip of the inner collet, which indicates the reduction/locking instrument was not placed on tabs as intended.It is possible the locker or reduction instrument was not properly aligned with the screw head, resulting in an unbalanced loading which exceeded the yield strength of the collet, leading to fracture.
Event or Problem Description
It was reported that the inner collet of 3 mesa sm stature deformity polyaxial screws broke during reduction of the rail intra-operatively.The screws were removed and replaced.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.This report will represent the second of three screws.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE 5.5X35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10353178
• Report Number: 3004774118-2020-00161
• Device Sequence Number: 11370623
• Product Code: NKB
• UDI-Device Identifier: 10888857046733
• UDI-Public: 10888857046733
• 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): 10/23/2020

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: 3001-05535
• Device Catalogue Number: 3001-05535
• Device Lot Number: EMBW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1