MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MULTILOK TABLE BASE; TABLE,

Model Number	0302-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Eject (4010)
Health Effect - Clinical Codes	Injury (2348); Needle Stick/Puncture (2462)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A staff member had difficulty releasing a hand table top from the base and was injured by a sharp edge on the top.
Event or Problem Description
A staff member had difficulty releasing a hand table top from the base and was injured by a sharp edge on the top.
Additional Manufacturer Narrative
This complaint was regarding a device manufactured by corin multilok tabletop and a device manufactured by mizuho osi multilok base.No previous complaints have been reported from (b)(6) 2017 to (b)(6) 2020.Multiple requests were made for the return, no device was returned for evaluation.The contribution of the multilok base cannot be confirmed through the investigation event cannot be confirmed through this.Requests regarding the return status were sent with no response received as of (b)(6) 2020.The table base was returned for evaluation.On visual inspection, the base was observed to be slightly bent.On functional evaluation, it was found to be working as intended, and most likely did not contribute to the finger punctures.

• Brand Name: MULTILOK TABLE BASE
• Common Device Name: TABLE,
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 10271203
• Report Number: 2921578-2020-00023
• Device Sequence Number: 14109411
• Product Code: FWZ
• UDI-Device Identifier: 00842430111167
• UDI-Public: 00842430111167
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 0302-001
• Device Catalogue Number: 0302-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/05/2021
• 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