MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY ONE LEVEL PLATE SIZE 14; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811114
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Spring bar popped off plate when advancing screw on adjacent side of the plate.The 10 minute delay to replace plate and screws.No adverse consequences were reported.
Event or Problem Description
Spring bar popped off plate when advancing screw on adjacent side of the plate.10 minute delay to replace plate and screws.No adverse consequences were reported.
Additional Manufacturer Narrative
The spring bar was visually confirmed to be deformed on the returned device.Dimensional and materials analysis were not completed due to the deformation being confirmed through visual inspection, as well as communication with the representative.Manufacturing files were reviewed and no anomalies were found.Conclusion: plausible root cause cannot be determined.Potential causes may be: user tilts guide off axis affecting screw path.Over-angulation of screwdriver which leads to unintended cantilever force.Guide not properly attached to plate.Guide/awl limits visibility.Blocker in locked position and spring bar does not freely move as screw progresses.
Additional Manufacturer Narrative
The spring bar was visually confirmed to be deformed on the returned device.Dimensional and materials analysis were not completed due to the deformation being confirmed through visual inspection, as well as communication with the representative.Manufacturing files were reviewed and no anomalies were found.Conclusion: plausible root cause cannot be determined.Potential causes may be: user tilts guide off axis affecting screw path.Over-angulation of screwdriver which leads to unintended cantilever force.Guide not properly attached to plate.Guide/awl limits visibility.Blocker in locked position and spring bar does not freely move as screw progresses.
Event or Problem Description
Spring bar popped off plate when advancing screw on adjacent side of the plate.10 minute delay to replace plate and screws.No adverse consequences were reported.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7884623
• Report Number: 0009617544-2018-00223
• Device Sequence Number: 19514599
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: 07613252152118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/15/2018

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: 48811114
• Device Lot Number: 172769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1