MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVTY HNGD SWNG ARM SYST; APRON, LEADED

Model Number	ZGHSA
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During preventative maintenance, it was noticed by the technician, that the set screws and jam nuts are not to oem standards.
Additional Manufacturer Narrative
H3: during preventative maintenance, it was noted by service technician that the set screws and jam nuts on the unit did not meet oem standards.The unit was previously purchased from another hospital, though the date of purchase is unknown.The unit was also relocated at some point.This is an older model originally sold by cfi.To bring the unit back to oem standards, replacement of the upper boom arm would be required.Based on available information, the deviation appears to be the result of aftermarket modifications or repairs performed outside of tidi¿s control.Device evaluation: the unit was not returned for formal evaluation.However, the reported findings suggest use of non-original parts not supplied or installed by the manufacturer.No internal sme involvement is required at this time, and the issue appears related to unauthorized alterations rather than a manufacturing defect.Manufacturer reference file: (b)(4).

• Brand Name: ZERO GRAVTY HNGD SWNG ARM SYST
• 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: 23639314
• Report Number: 2182318-2025-00102
• Device Sequence Number: 21146970
• Product Code: EAJ
• UDI-Device Identifier: 00618125176229
• UDI-Public: 00618125176229
• Combination Product (Y/N): N
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: ZGHSA
• Device Catalogue Number: ZGHSA
• Device Lot Number: 567605-3
• 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: 10/22/2025
• Initial Report FDA Received Date: 11/24/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown