MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MULTILOK TABLE BASE; HAND 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	04/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Staff was dismantling sterile field post procedure.When disengaging the multi lok hand table top from the base the disposable top punctured through the staff's gloves.She noticed three puncture holes through her left fifth finger.Went to emergency and received hepatitis c prophylaxis.Subsequent information received from the facility indicates there is some difficulty removing the (corin) top from the (b)(6) which contributed to the problem.
Event or Problem Description
Staff was dismantling sterile field post procedure.When disengaging the hand table top from the base the disposable top punctured through the staff's gloves.She noticed three puncture holes through her left fifth finger.Went to emergency and received hepatitis c prophylaxis.Subsequent information received from the facility indicated there was some difficulty removing the (corin) top from the (mizuho osi) base which contributed to the problem.
Additional Manufacturer Narrative
Most probable root cause is user error as multilok table bases, (b)(6), were functioning as intended.Multilok¿ hand surgery table system is meant to be used with pre-sterilized table top and accessories constructed of high quality plastic for single use.When releasing the lock lever the single use plastic accessories break in order to prevent multiple uses.

• Brand Name: MULTILOK TABLE BASE
• Common Device Name: HAND TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 10271279
• Report Number: 2921578-2020-00022
• Device Sequence Number: 3495695
• 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): 07/13/2021

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
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/13/2021
• 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: Required Intervention