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	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative implant placement the navigator straight inserter became deformed at the tip.There were no adverse consequences to the patient or reported surgical delays.
Event or Problem Description
It was reported that during intra-operative implant placement the navigator straight inserter became deformed at the tip.There were no adverse consequences to the patient or reported surgical delays.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed that the tip of the inserter was deformed and one leg of the clasping mechanism was splayed outwards.Material discoloration was identified on the tip.Device history records were reviewed for the corresponding lot and no relevant issues were identified.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It was initially reported that the avs navigator straight inserter tip experienced deformation during use which was confirmed via visual inspection.The inserter tip deformed when the implant was rotated in the intervertebral space.Upon visual inspection of the returned device, it was confirmed that one leg of the clasping mechanism was splayed outwards as if excessive force was applied during implant rotation.It was further reported that the implant was inserted at difficult angle (l5-s1 level).This device was manufactured in june 2019 and repeated use of the device throughout its service life contributed to tip deformation.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.

• 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: 13604487
• Report Number: 0009617544-2022-00024
• Device Sequence Number: 19321834
• 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): 06/03/2022

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?: Yes
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 06/03/2022
• 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 Sex: Unknown