MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. COUPLER II, MAIN ASSEMBLY; TABLE ACCESSORIES

Model Number 5873

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2018

Event Type  malfunction  

Event Description

It was reported on (b)(6) 20/18 coupler ii was connected to mizuho/osi 5803 table with spine frame.Coupler ii was connected to the mayfield aluminum skull clamp utilizing the mizuho/osi coupler ii p/n 5873 and adapter p/n 5873-30.While locking the adapter to the coupler ii with patient positioned in the mayfield skull clamp, the large yellow screw connector broke.

Manufacturer Narrative

Unable to determine root cause due to product not returned for evaluation.Further discussion revealed that the screws did not break during patient positioning.Most likely cause of why the yellow screw was found broken could be due to the unit being dropped or mishandled.The owner's manual advises the users to inspect the device before each use.

Event Description

It was reported on (b)(6) 2018 coupler ii was connected to mizuho/osi 5803 table with spine frame.Coupler ii was connected to the mayfield aluminum skull clamp utilizing the mizuho/osi coupler ii p/n 5873 and adapter p/n 5873-30.While locking the adapter to the coupler ii with patient positioned in the mayfield skull clamp, the large yellow screw connector broke.

• Brand Name: COUPLER II, MAIN ASSEMBLY
• Type of Device: TABLE ACCESSORIES
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 7266216
• MDR Text Key: 100145979
• Report Number: 2921578-2018-00003
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5873
• Device Catalogue Number: 5873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other