MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; KNEE IMMOBILIZER

Model Number A143000

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the complaint sample was returned, the product shows sign of wear and use.When looking at a fully assembled product, the wide ends of the panels belong to the wide ends of the brace body, and the contoured shape of the stay fits properly to the curve at the back of the calf.For adjustability, this item is equipped with removable side panels and a trimmable body.On the returned sample, the panels have been removed and adjusted.However, when they were placed back on the brace the wide ends of the panels were placed on the narrow end of the brace.Essentially the brace was being worn upside down by the end user, making the contour incorrect and uncomfortable.Product on hand was reviewed, no error/defects were found in house.(b)(4).Root cause: this appears to be a fitting issue.On the returned sample, the panels have been removed and adjusted.When they were placed back on the brace the wide ends of the panels were placed on the narrow end of the brace.Essentially the brace was being worn upside down by the end user, making the contour incorrect and uncomfortable.Corrections: replacement product was requested and sent.Corrective action: there is no action required at this time, there were no issues or defects found in house.Preventive action: there is no preventive action required at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

The quality issue details and the outcome details section copied below are responses given by the initial reporter to the deroyal complaint questionnaire.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: metal bar in back is curved and is causing pain in the back of her thigh.How was the quality issue was identified? by actual use.How was the product being used? as described.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.

• Brand Name: DEROYAL
• Type of Device: KNEE IMMOBILIZER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a; villa canales; villa canales, guatemala 01065 ; GT 01065
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5815194
• MDR Text Key: 51036766
• Report Number: 3010452421-2016-00016
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2016,07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A143000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 06/23/2016
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other