MAUDE Adverse Event Report: TIDI PRODUCTS LLC TAT LIMB HOLDER;2700Q; RESTRAINT, PROTECTIVE

Model Number	2700Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer is reporting a complaint on product 2700q restraint.Customer states during education/training that the push down part that releases the buckle broke off during normal usage.Tm states that the device has been used numerous times for trainings.Some concern was raised over repetitive/long term use and any recommended useful life information.No patient injury.
Additional Manufacturer Narrative
Product was received and evaluated.Visual findings observed the small internal center component corresponding to the middle press area is fractured and separated from the main buckle body.The fracture surface appears clean, with no obvious discoloration or deformation visible.The webbing strap is intact with no evidence of tears, cuts, fraying, or excessive wear.Evaluation of the returned device indicates that the quick-release buckle is capable of securing and releasing when engaged and manually actuated.However, due to the missing center release component, the buckle no longer represents the intended three-point release design, which requires simultaneous activation of all three points, two side tabs and the center press feature for proper use.Despite the fractured internal center component, the affected buckle continues to latch properly when the male and female ends are connected and can be disengaged through activation of the release mechanism.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, cracked or broken buckles or locks, and/or that hook-and-loop adheres securely, as these may allow patient to remove cuff.Additionally, the ifu warns do not use this device on a patient who is or becomes: suicidal, highly aggressive or combative, self-destructive, or deemed to be an immediate risk to others, unless the patient is under constant supervision.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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: TAT LIMB HOLDER;2700Q
• Common Device Name: RESTRAINT, PROTECTIVE
• 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: 25610392
• Report Number: 2182318-2026-00063
• Device Sequence Number: 9972201
• Product Code: FMQ
• UDI-Device Identifier: 10190676002792
• UDI-Public: 10190676002792
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 2700Q
• Device Catalogue Number: 2700Q
• Device Lot Number: 6078T071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2026
• 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