MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVITY HINGED MONORAIL SYSTEM; APRON, LEADED

Model Number	ZGCM-HSA
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Zero gravity cable outer sleeve is damaged.If the damage to the cable outer coating results in debris or fragments that may then fall into the sterile field, this could result in patient injury and is therefore mdr reportable.
Additional Manufacturer Narrative
H3: device is not available for evaluation; therefore this report is based solely on the information provided by the customer.H10: this malfunction was initially reported to the distributor, biotronik.It was reported that the balancer cable outer sleeve or coating was damaged, and images of the damage were provided.Historical complaint data review identified one other similar complaint for damage to the balancer cable outer coating documented in the last 5 years.Review of the photo provided by the customer showed damage consistent with burning, like blackened edges and melted shriveled plastic where the sheath was no longer surrounding the cable, however no damage to the cable itself was observed.The customer was contacted for additional information regarding maintenance and usage of the device, but no additional information has been received so far.The customer was advised to discontinue use of the device until the balancer can be replaced.After analyzing all customer provided information and evidence, and reviewing the system component design and operation, the conclusion drawn from this complaint was most likely caused by a thermal event unrelated to the design of the zero-gravity unit.Currently, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.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).

• Brand Name: ZERO GRAVITY HINGED MONORAIL SYSTEM
• 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: 21339548
• Report Number: 2182318-2025-00010
• Device Sequence Number: 14415408
• Product Code: EAJ
• UDI-Device Identifier: 00618125176144
• UDI-Public: 00618125176144
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: ZGCM-HSA
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown