MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL FOOT/ANKLE ORTHOSIS; WALKER BOOT

Model Number 1-507A-05

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 04/02/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the complaint sample was returned.The product looked new and unused.It is possible that it was only worn during fitting.No defects were reported in the complaint, only that is was uncomfortable on the leg.The product was inspected and no vendor/manufacturing defect was found.Root cause: the investigator was unable to determine root cause as no manufacturing defect/ or issue was found.It is possible that this boot was just not well suited to the end users injury and/or condition.Corrections: replacement product was requested and sent.Corrective action: there is no action required at this time, the returned sample was not found to be defective.Preventive action: there is no action required at this time, the returned sample was not found to be defective.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

Quality issue details : date of occurrence: (b)(6) 2016.When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? patient/end consumer.Was a medical procedure involved? no.Name of medical procedure: not applicable.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: patient said the brace was very painful.Extra pads did not help.They returned the product - said that the leg hurt too much.Patient was put in a cast.How was the quality issue was identified? by actual use.How was the product being used? normal use.Was it the initial use of the product? yes.Was the product modified from the original condition supplied by deroyal? no.Was the product connected to or used in conjunction with other devices or equipment? no.Outcome details: outcome(s) attributed to quality issue: none.Person(s) affected by outcome(s) checked above: patient.Known pre-existing condition(s) of person(s) affected: none specified.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: please replace the product.

• Brand Name: DEROYAL FOOT/ANKLE ORTHOSIS
• Type of Device: WALKER BOOT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): ELITE ORTHOPAEDICS, INC.; 1535 santa anita avenue; south el monte CA 91733
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5594869
• MDR Text Key: 44182838
• Report Number: 1060680-2016-00004
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016,04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1-507A-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 04/05/2016
• Date Manufacturer Received: 04/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other