MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRVTY FLR SYSTM 6.5' ARM; APRON, LEADED

Model Number	ZGM-6-5H
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: on (b)(6), 2026, tidi was contacted by the customer regarding a quote for a broken end stop that is located on the top of the block assembly.It was reported that one of the two screws of the stop block were sheared off and it is unknown how it broke.On (b)(6) 2026, the customer again contacted tidi and informed us that the screws had been sheared off while the unit was being moved by an unknown individual.As a result, the boom arm rotated and reportedly caused injury to two individuals; however, the identities of the individuals and the nature or severity of the injuries were not provided.The report did not indicate that the unit tipped over.An attempt was made to gather more information about the event and injuries, but no further information was available.At the time of reporting, the unit is under the user¿s quality assurance control for investigation to determine root cause.The instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Per the ifu: ¿the floor unit may be moved to other rooms if disassembly is not required.If disassembly is required, contact tidi products service.¿ at this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.All complaints are trended and reviewed by management on a monthly basis.As part of this review process, any excursion above established control limits for this failure mode is assessed, documented, and addressed as appropriate.Manufacturer reference file: (b)(4).
Event or Problem Description
The screws were sheared off when moving the unit by unknown and the boom arm rotated injuring 2 people (unknown who and what injury) but did not mention the unit tipping over.

• Brand Name: ZERO GRVTY FLR SYSTM 6.5' ARM
• Common Device Name: 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: 24628623
• Report Number: 2182318-2026-00034
• Device Sequence Number: 18315001
• Product Code: EAJ
• UDI-Device Identifier: 00618125176250
• UDI-Public: 00618125176250
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ZGM-6-5H
• Device Catalogue Number: ZGM-6-5H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown