MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO LL FIXATION ANCHOR, 45MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48940045
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgery type: l3-4 & l2-3 lateral interbody fusion all issues occurred at l3-4 level which was performed first.2nd level (l2-3) went as expected without any complications.During insertion of pilot cutter the tip of the cutter was deformed (bent upward) as the cutter was driven forward into the side of the vertebral body.During insertion of the 1st and 2nd blades of the device blades deformed (leading edge bent upward and the top part of the blade sheared completely resulting in blade fracture).The superior blade was left in bone in its fractured state (removal was not possible).The inferior blade was removed after observing significant deformation of the blade prior to complete insertion.The surgical delay associated with blade removal and troubleshooting was approximately 30 minutes.Additionally, having 1 pilot cutter in the national loaners set does not allow for any back-up instrumentation to complete the surgery.This is an easily identifiable inventory issue that compounded the initial product related issue.Fluoroscopic images showing progression of pilot cutter deformation and blade/anchor deformation and fracture are available,.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be related to the bent of the pilot cutter prior to the anchor insertion.
Event or Problem Description
It was reported that; surgery type: l3-4 & l2-3 lateral interbody fusion all issues occurred at l3-4 level which was performed first.Second level (l2-3) went as expected without any complications.During insertion of pilot cutter the tip of the cutter was deformed (bent upward) as the cutter was driven forward into the side of the vertebral body.During insertion of the 1st and 2nd blades of the device blades deformed (leading edge bent upward and the top part of the blade sheared completely resulting in blade fracture).The superior blade was left in bone in its fractured state (removal was not possible).The inferior blade was removed after observing significant deformation of the blade prior to complete insertion.The surgical delay associated with blade removal and troubleshooting was approximately 30 minutes.Additionally, having 1 pilot cutter in the national loaners set does not allow for any back-up instrumentation to complete the surgery.This is an easily identifiable inventory issue that compounded the initial product related issue.Fluoroscopic images showing progression of pilot cutter deformation and blade/anchor deformation and fracture are available.

• Brand Name: AERO LL FIXATION ANCHOR, 45MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6230957
• Report Number: 0009617544-2017-00003
• Device Sequence Number: 10872588
• Product Code: MAX
• UDI-Device Identifier: 07613327066203
• UDI-Public: (01)07613327066203
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

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 Catalogue Number: 48940045
• Device Lot Number: 14G480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR