MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 16; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48811116
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; one of the bars from the locking mechanism of the aviator plate was bent and sort of broken.The surgeon noticed the plate was after implanting the screws and when he looked under the microscope he noticed the bent, almost broken bars.Surgeon removed the screws and the plate and put another plate in.No adverse consequences to the patient and no surgical delay.Procedure was completed successfully.
Additional Manufacturer Narrative
Lot# 14c849.Method: visual inspection, device history review, complaint history review, risk assessment.Result: manufacturing files were reviewed and no anomalies were found.Conclusion: the potential root cause include: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
It was reported that; one of the bars from the locking mechanism of the aviator plate was bent and sort of broken.The surgeon noticed the plate was after implanting the screws and when he looked under the microscope he noticed the bent, almost broken bars.Surgeon removed the screws and the plate and put another plate in.No adverse consequences to the patient and no surgical delay.Procedure was completed successfully.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 16
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6599812
• Report Number: 0009617544-2017-00228
• Device Sequence Number: 1088861
• Product Code: KWQ
• UDI-Device Identifier: 07613252152125
• UDI-Public: (01)07613252152125
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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 Model Number: 48811116
• Device Catalogue Number: 48811116
• Device Lot Number: 14C849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1