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

Model Number 3001-05535

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2020

Event Type  malfunction  

Event 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 first of three screws.

Event 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 first of three screws.

Manufacturer Narrative

Visual inspection: upon inspection of the returned device, the outer collet was found disengaged from the inner collet.The stake pin, the pin that connects the outer and inner collet, had sheared from the inner collet.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were 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.The loading placed between the collets during reduction likely exceeded the yield strength of the stake pin, causing the pin to shear and the outer collet to disengage.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE 5.5X35 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10353173
• MDR Text Key: 202083030
• Report Number: 3004774118-2020-00160
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857046733
• UDI-Public: 10888857046733
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3001-05535
• Device Catalogue Number: 3001-05535
• Device Lot Number: EJDP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 09/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1