MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X18 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 8801-04018DA

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Lot unknown (1): device not returned.The device was not returned and could not be inspected.Device history records could not be reviewed without either the device or a valid lot number.Complaint history for the reported catalogue number was reviewed and no adverse trends were identified.A conclusive root cause can not be determined with the available information.Lot phfa (1): device returned 28 april 2022.Visual inspection of returned device confirms that the threading is fractured and deformed.There are threads fractured at two locations on the screw; one close to the proximal head and one just distal of the midpoint of the screw.Both fractures occurred at the outer edge of the thread.Fractured threads are deformed proximally.Thread deformation is observed around the fractures.The location and direction of fracture and deformation of threads indicates that the screw was most likely over angulated during insertion and was damaged by the plate.Complaint history for the reported lot number was reviewed and no adverse trends were identified.The most likely cause of the reported event was determined to be due to screw over angulation during insertion.This is supported by the visual inspection of the device as well as information from the field.Variable screws can be inserted ±15º, in any direction relative to the neutral angle of the screw hole.If they are outside of this limit, the plate may damage the screw threads.

Event Description

This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instances of intraoperative ozark self-starting variable screw fracture.In one instance, the fractured shaft of the device remains implanted in the patient's bone.In both instances, the associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X18 MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15136256
• MDR Text Key: 302691219
• Report Number: 3004774118-2022-00306
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10888857393400
• UDI-Public: 10888857393400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172104
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2022

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
• Device Operator: Health Professional
• Device Model Number: 8801-04018DA
• Device Catalogue Number: 8801-04018DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1