MAUDE Adverse Event Report: TIDI PRODUCTS LLC LOCKING TWICE-AS-TOUGH CUFFS ANKLE; RESTRAINT, PROTECTIVE

Model Number	2793
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
Per the customer: patient was in mechanical restraints today, the lower limb restraint completely broke which released the limb.Lot #1181t090; sku 2793.No incident or injuries reported.
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.Product was not returned for evaluation but pictures of the failed area were provided.Based on the images the bed connecting strap has broken stitches at the box stitch causing the product to come apart.This is a known issue and has been addressed internally via corrective action.A device history record (dhr) of the affected serial number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The unit passed all verification testing and met manufacturing specifications prior to being released for distribution.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Per the ifu: before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.Additionally, the ifu warns: do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.And additional or different body or limb restraints may be needed: if the patient pulls violently against the bed straps.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 2024-00700.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS ANKLE
• 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: 19774621
• Report Number: 2182318-2024-00089
• Device Sequence Number: 8371834
• Product Code: FMQ
• UDI-Device Identifier: 10190676002723
• UDI-Public: 10190676002723
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/21/2024

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: 2793
• Device Catalogue Number: 2793
• Device Lot Number: 1181T090
• 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: 06/21/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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