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

Model Number 5873

Device Problem Break (1069)

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

Event Date 01/23/2020

Event Type  malfunction  

Event Description

When the operator turned the knob during surgery, it broke halfway.Therefore, they fixed the coupler by chucking the thread with pliers.

Manufacturer Narrative

The root cause of the break appears to be due to pilers being used on the threaded part of the knob.The performance of the knob prior to the use of the pilers cannot be determined.A visual inspection indicated that actions outside of normal use contributed or caused the break.

Event Description

As reported, when the operator turned the knob during surgery, it broke halfway.Therefore, they fixed the coupler by chucking the thread with pliers.

• Brand Name: COUPLER II, MAIN ASSEMBLY
• Type of Device: COUPLER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 9811172
• MDR Text Key: 183885724
• Report Number: 2921578-2020-00014
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104534
• UDI-Public: 00842430104534
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1