MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; FULL SHELL WALKER 2, LARGE

Model Number 1-524A-04-CFSM

Device Problems Hole In Material (1293); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the returned product is very well worn.The liner developed several holes during wear and use.There were two holes at the top of the boot and one at the heel (see attached files (b)(4)).These holes go all the way through the foam liner, allowing the leg to be exposed to the hook tabs that are placed inside the frame to secure the liner to the shell.These holes form during wear/use when the straps are not properly tightened.Loose straps allow the liner/leg to move/rub against the hook tabs inside the shell, causing the foam material to break down.There was no vendor defect was found.Correction: credit was requested/issued.Root cause analysis: the complaint investigator found no vendor or manufacturing defect.It appears that the straps may not have been tightened enough to eliminate leg/liner movement within the shell.Corrective action and/or systemic correction action taken: there is no action required at this time, no vendor/manufacturing defect was found.Preventive action: there is no action required at this time, since no vendor or manufacturing defect was found.

Event Description

Below is a copy of the complaint call questions asked by deroyal about the event and the corresponding responses made by the initial reporter.When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? patient was a medical procedure involved? no.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: i replaced this patient's large, tall pneumatic walking boot because the material was coming apart at the heel and causing pain.The pain was on the heel.There was no injury or blister reported.How was the quality issue was identified? by actual use.How was the product being used? on the foot.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.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: patient was given a new brace.

• Brand Name: DEROYAL
• Type of Device: FULL SHELL WALKER 2, LARGE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer Contact: marian vargas ; 200 debusk lane; powell, TN 37849 ; 8653621013
• MDR Report Key: 5095286
• MDR Text Key: 26742970
• Report Number: 1060680-2015-00041
• Device Sequence Number: 1
• Product Code: KNP
• 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
• Report Date: 08/28/2015,09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1-524A-04-CFSM
• Device Catalogue Number: 86275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2015
• Event Location: Home
• Date Report to Manufacturer: 08/28/2015
• Date Manufacturer Received: 08/28/2015
• 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