MAUDE Adverse Event Report: JOIMAX, INC. UNKNOWN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problems Bent (1059); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Event Description

My team and i were doing a minimally invasive discectomy with the use of joimax.The dr.Prepped and draped the patient and surgery was underway.The joimax was hooked up properly and all of the equipment we needed was in the room.When it came time for the dr.To use bipolar cautery the foot pedal was not communicating with the joimax machine and the cautery was not working.The rep was made aware and he began trying to diagnose and figure out what the problem was.The neuro supervisor was also called down to the room to try and figure out what the problem was and also to brainstorm how we could fix this issue.The rep was not able to fix the pedal (the connecting prongs were bent and not fitting into the joimax machine properly), and because this was our only machine and pedal the dr.Was not able to use the equipment the way it was intended.The pt experienced no harm but the broken equipment was a safety concern creating an unsafe environment therefore the dr.Decided to cancel his next case which was also scheduled with joimax.

• Brand Name: UNKNOWN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): JOIMAX, INC.; 733 bolsana dr.; laguna beach CA 92651
• MDR Report Key: 6383450
• MDR Text Key: 69222005
• Report Number: 6383450
• Device Sequence Number: 0
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 47587
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR