MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVITY HINGE KIT; APRON, LEADED

Model Number 31840-100

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Summary: this event was initially reported to the distributor, biotronik.It was reported that the hinge, which is located within the body shield and can move the body shield lead closer to or further away from the user, broke while the device was in use with a patient.There was no patient or caregiver injury reported as a result of this event.This is the fist instance reported by the manufacturer (tidi) of a hinge breaking while the device is in use with a patient.Wear out of the hinge is expected over the life of the system, though the hinge is required to have a minimum of a 5-year useful life.There are historical instances of early failures which lead to a design change in october 2018.The device associated with this event was manufactured in 2012 and is approximately 11 years old at the time of the failure.There have been no other complaints or replacement parts orders documented for this unit, based on a review of historical complaint data.The actual hinge involved in the incident is not available for evaluation, but images of the broken hinge were provided.Upon review of these images by a cross-functional team familiar with this product and it¿s use, it was determined that the damage seen is consistent with what would be considered normal wear and tear of the hinge.Per the instructions for use (ifu) ¿the zero-gravity system requires annual preventative maintenance, inspection, and general cleaning throughout its life.¿ at this time 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).

Event Description

3-27-2023: zg part c hinge - right side is broken, last follow up with normal results ((b(6) 2022 ) box checked that damage occurred during implantation procedure which did not cause adverse change in the patients condition customer is looking for replacement.

• Brand Name: ZERO GRAVITY HINGE KIT
• 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: 17029906
• MDR Text Key: 316213198
• Report Number: 2182318-2023-00046
• Device Sequence Number: 1
• Product Code: EAJ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2023

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: 31840-100
• Device Catalogue Number: 31840-100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1