MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINE GUIDANCE SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 6002-710-000

Device Problems Display or Visual Feedback Problem (1184); Incorrect Measurement (1383); Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  malfunction  

Event Description

Per the customer, licensing for the automated functionality portion of the q guidance system was not loaded correctly.The customer instead used the non-automated software package available with the q guidance system.While placing a hip pin, movement was shown on the screen without moving the device.Two of the eight screws were shown medial after following the planned projection.Per the customer, it appeared the screws shifted.Additional information has been requested from the user facility.

Event Description

Per the customer, licensing for the automated functionality portion of the q guidance system was not loaded correctly.The customer instead used the non-automated software package available with the q guidance system.While placing a hip pin, movement was shown on the screen without moving the device.Two of the eight screws were shown medial after following the planned projection.Per the customer, it appeared the screws shifted.The procedure was completed successfully without a clinically significant surgical delay; no medical intervention or adverse consequences were reported.

Manufacturer Narrative

Update: h3, h6 device evaluation: follow-up report submitted to document the device evaluation.

• Brand Name: SPINE GUIDANCE SOFTWARE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16279367
• MDR Text Key: 308916583
• Report Number: 3015967359-2023-00350
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07613327545883
• UDI-Public: 07613327545883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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
• Device Model Number: 6002-710-000
• Device Catalogue Number: 6002-710-000
• Device Lot Number: VERSION: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1