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

Model Number 48811116

Device Problems Bent (1059); Break (1069); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6599812
• MDR Text Key: 76396292
• Report Number: 0009617544-2017-00228
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152125
• UDI-Public: (01)07613252152125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 05/04/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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