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

Model Number	5873
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while trying to position an unstable cervical spine, the mayfield osi coupler assembly adapter failed to tighten.Patient had an injury/laceration as a result of the malfunction.
Event or Problem Description
It was reported while trying to position an unstable cervical spine, the mayfield osi coupler assembly adapter failed to tighten.Patient received a minor laceration.
Additional Manufacturer Narrative
The equipment that was returned appeared to be in good condition.Testing showed that the device meets it specification; it locks in position and supports a load as expected.Unable to determine a reason why the users were unable to secure the device.No physical cause found.User error is suspected.

• Brand Name: COUPLER II
• Common Device Name: COUPLER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca CA 94587 1234
• MDR Report Key: 9251713
• Report Number: 2921578-2019-00040
• Device Sequence Number: 19423765
• Product Code: JEA
• UDI-Device Identifier: 00842430104534
• UDI-Public: 00842430104534
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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 Model Number: 5873
• Device Catalogue Number: 5873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other