MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR STRAIGHT INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48393001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative cage placement, the tip of an avs navigator inserter became deformed.There were no adverse consequences to the patient or surgical delays.
Additional Manufacturer Narrative
A visual inspection performed on the device confirmed that the tip of the inserter was deformed.One leg of the clasping mechanism is splayed outwards.Material wear was identified on the tip.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for the lot and subject catalog number and no adverse trends were observed.Initial report states that the inserter tip deformed when the implant was rotated in the intervertebral space.Per additional information, the implant was inserted at difficult angle.Avs navigator surgical technique was reviewed: ¿ "manual assembly: slide implant back rail on inserter track.Rotate until locking bar and rail slot are aligned.Locking bar and rail slot are aligned.Locking the implant: provisionally lock the implant by pressing down and pushing the slide lock forward to the ¿lock¿ position.This pushes the locking bar into the rail on the implant.Rotate the locking knob clockwise until the outer sleeve on the distal end of the implant is flush with the implant and the locking knob is in the ¿lock¿ range." the root cause of the reported event is deformation due to normal wear, consistent, repetitive use of the instrument, and excessive rotation force applied to the device during implant rotation to accommodate for difficult insertion angle.Additionally, as the device is 3 years old, age of device may have contributed to event, and repeated use of the device throughout its service life contributed to tip deformation.
Event or Problem Description
It was reported that during intra-operative cage placement, the tip of an avs navigator inserter became deformed.There were no adverse consequences to the patient or surgical delays.

• Brand Name: NAVIGATOR STRAIGHT INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13933027
• Report Number: 0009617544-2022-00037
• Device Sequence Number: 4731768
• Product Code: MAX
• UDI-Device Identifier: 07613327096194
• UDI-Public: 07613327096194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151726
• 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): 07/05/2022

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: Health Professional
• Device Model Number: 48393001
• Device Catalogue Number: 48393001
• Device Lot Number: 17C017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female