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

Model Number 2793

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The product has been requested to be returned for evaluation and has not been received.Therefore, this report is based solely on the information provided by the customer.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.The ifu states 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.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.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).

Event Description

The customer would like to return product for inspection and report.The customer states that their restraints 2793 failed.Customer states that patients were able to cause the restraints to tear away at the box seam.

Manufacturer Narrative

Several attempts were made to get the device back for evaluation, but the device was not returned.This report is based solely on the information provided by the customer.A historical review of the complaint database revealed two similar complaints in the last 2 years.One of those complaints was not returned for evaluation, so only one complaint was received and evaluated.The stitching was visually observed to be coming apart as reported.The device history record (dhr) of the affected lot number revealed that there were (b)(4) pairs of restraints being produced as finished goods.Based on the lot size and acceptable quality level (aql) 4.0, eleven pair of restraints ((b)(4) data points) were pulled from the inventory to replicate the stitching or seam separation.All sample products were tested for tensile strength failures using a calibrated pull tester.The force reading after the box x stitching (square tacks) were separated ranged from 467.15 to 670.99 lbs.Of force with an average of 537.14 lbs.Of force, thus indicating that all samples tested passed the minimum force requirement of 300 lbs.Of force.For these samples, the box x stitch has been identified as the failure, but no determination on a root cause could be reached based on the returned product and the tensile testing performed.As part of root cause analysis, it was hypothesized that the box stitch failures could result from running out of thread during production or not enough stitching, however there are preventative measures in place to ensure that the stitching is adequate.Though testing confirmed the product to meet specifications, tidi has identified an opportunity for improvement in the process controls for the box stitching volume.It is believed that a machine setting variability could potentially create variability in the strength results.As such, tidi is implementing corrective measures to reduce that variability moving forward by updating the manufacturing work instructions to include the square tack program including stitch quantities, by updating the restraint inspection plan to include verification of the square tack program and stitch quantity, and training on document updates.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, 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.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.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.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).H3 other text : product not returned.

Event Description

Supplemental medwatch required for additional information.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS ANKLE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15754288
• MDR Text Key: 307616044
• Report Number: 2182318-2022-00128
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002723
• UDI-Public: 10190676002723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

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: 2220T109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1