MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR DISC SPACE DISTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48394005
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that an avs navigator dynamic distractor jammed intra-operatively and that the tip deformed.The procedure was completed successfully with a 10 minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Additional data: d4, d9, h3, h4.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: NAVIGATOR DISC SPACE DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 22102449
• Report Number: 0009617544-2025-00051
• Device Sequence Number: 7276546
• Product Code: LXH
• UDI-Device Identifier: 07613327270709
• UDI-Public: (01)07613327270709(11)200309(10)197186
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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 Catalogue Number: 48394005
• Device Lot Number: 197186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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