MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR STRAIGHT INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48393001
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the inserter tip became loose and was came off the cage.The surgery was completed with other cage.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The device was inspected and the tip was found to be slightly splayed.The plausible root cause is excessive force applied by the user.
Event or Problem Description
It was reported that; during surgery, the inserter tip became loose and was came off the cage.The surgery was completed with other cage.

• Brand Name: NAVIGATOR STRAIGHT INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6424916
• Report Number: 0009617544-2017-00106
• Device Sequence Number: 18957836
• Product Code: LXH
• UDI-Device Identifier: 07613327096194
• UDI-Public: (01)07613327096194
• Combination Product (Y/N): N
• 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): 05/23/2017

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: 48393001
• Device Lot Number: 14F898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR