MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVTY FLOOR SYSTEM 6.5' ARM; APRON, LEADED

Model Number ZGM-6-5H

Device Problem Unintended Movement (3026)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

This event was initially reported to the distributor, biotronik.It was reported on (b)(6) 2023, that the stop block which holds the boom arm in place broke during a case.The block is held on by 2 allen bolts and was broken, one of the bolts had sheared off.Biomedical engineering removed the block from the unit completely.While the unit was being moved out of the lab for repair, the boom arm swung 180 degrees, shifting the weight of the unit and it tipped over.A technician who was involved in the case intervened attempting to cushion the fall and strained her back.Upon follow-up a week later, it was reported that the technician was okay and had returned to work.The original failure of the stop block was not reported to tidi (manufacturer) or biotronik (distributor).An unauthorized repair was completed by biomedical engineering at the user facility and the device was returned to use.Upon manufacturer awareness of the event, the user facility was instructed not to use the device until a company representative can review the unit.Unit was reviewed on january 24, 2023 by a trained technician and returned to oem standards.Root cause for the original failure is unknown.The unit was manufactured in 2019.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Per the instructions for use (ifu) ¿the floor unit may be moved to other rooms if disassembly is not required.If disassembly is required, contact tidi products service.¿ all complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file: (b)(4).

Event Description

Informed via phone call by the biotronik distributor the following information: original product failure was not reported to tidi or biotronik - possible broken screw in stop block.Repaired performed by customer biomed.While moving the unit before or after the repair, it fell over.The person doing the moving of system has reported a sore back.

• Brand Name: ZERO GRAVTY FLOOR SYSTEM 6.5' ARM
• Type of Device: APRON, LEADED
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16296618
• MDR Text Key: 308782184
• Report Number: 2182318-2023-00003
• Device Sequence Number: 1
• Product Code: EAJ
• UDI-Device Identifier: 00618125176250
• UDI-Public: 00618125176250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2023

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?: No
• Device Model Number: ZGM-6-5H
• Device Catalogue Number: ZGM-6-5H
• Device Lot Number: 624523
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other