MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 34; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48811234
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking mechanism could not be turned to final position during the procedure.The plate had to be removed and replaced with new one with rescue screws.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the stryker rep confirmed that the blocker was initially tightened with a locking bit and then attempted with a "screwdriver without the inner stylet" which is the solid shaft screwdriver.Conclusion: the likely root cause is not turning the blocker with the solid screwdriver as recommended by the surgical technique.
Event or Problem Description
It was reported that the locking mechanism could not be turned to final position during the procedure.The plate had to be removed and replaced with new one with rescue screws.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing files were reviewed and no anomalies were found.Visual examination revealed that the blockers were in the locked position and had slight deformation, evidence of the screwdriver not being fully seated to the blocker.The blockers were able to be turned effortlessly using the proper instruments.Conclusion: the likely root cause is not fully seating the screwdriver into the blocker for turning of the blocker based on the visual evidence of deformation of the blocker.
Event or Problem Description
It was reported that the locking mechanism could not be turned to final position during the procedure.The plate had to be removed and replaced with new one with rescue screws.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 34
• 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: 5439567
• Report Number: 0009617544-2016-00062
• Device Sequence Number: 331937
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: 07613252152217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• 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,Followup
• Report Date (Section B): 01/21/2016

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: 48811234
• Device Lot Number: 147106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/16/2016
• Supplement Report FDA Received Date: 05/05/2016; 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1