MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATION ENABLED SERRATO/ES2/XIA 3 DRIVER, CANNULATED; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	48702681
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a navigation enabled serrato/es2/xia 3 cannulated driver disengaged from the screw during placement at s1.This altered the trajectory of the screw and made the screw hole too large.The surgeon opted to place a screw in the left iliac bone instead.The procedure was completed successfully with a 20-minute surgical delay and no reported adverse consequence to the patient.

• Brand Name: NAVIGATION ENABLED SERRATO/ES2/XIA 3 DRIVER, CANNULATED
• Common Device Name: ORTHOPEDIC STEREOTAXIC 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20322654
• Report Number: 0009617544-2024-00123
• Device Sequence Number: 15356888
• Product Code: OLO
• UDI-Device Identifier: 07613327460964
• UDI-Public: 07613327460964
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48702681
• Device Lot Number: 230483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female