MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48844014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was undergoing a 2 level acdf procedure when the top of the screw had broken and some debris had come off the screw during insertion.The surgeon had just engaged the screw with the bone and did not screw in when he noticed the screwdriver move and the breakage appeared.
Additional Manufacturer Narrative
Method: visual inspection( photos), labelling review, risk assessment result: the customer reported event was confirmed via the photos examination.The fragments removed without delay.The device was not returned and lot number was not provided, so manufacturing records review could not be completed.It was reported that the punch awl and drill was used as per recommended by the surgical technique guide and that the patient had good bone quality.Conclusion: the possible causes include screw inserted at an angle, drill guide/awl not attached to plate securely, drill guide/awl attached outside of design range.
Event or Problem Description
It was reported that the patient was undergoing a 2 level acdf procedure when the top of the screw had broken and some debris had come off the screw during insertion.The surgeon had just engaged the screw with the bone and did not screw in when he noticed the screwdriver move and the breakage appeared.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7797478
• Report Number: 0009617544-2018-00201
• Device Sequence Number: 1535395
• Product Code: KWQ
• UDI-Device Identifier: 07613252254706
• UDI-Public: 07613252254706
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K142237
• 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): 10/23/2018

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: No Information
• Device Catalogue Number: 48844014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1