MAUDE Adverse Event Report: PREMIER GUARD ZHONGSHAN LIMITED DEROYAL; WALKING BOOT

Model Number 15540006

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: customer complained that the sole cracked in half.There was no patient injury reported.The complaint sample returned.The lot number was found on the sample itself.This issue has been seen before.In 2010, this issue was found and corrected by the vendor on the gluing of the rubber sole bottom.From the lot number the deroyal was able to verify that this product was made before the vendor corrective action was implemented.The complaints (sole ungluing issues) to sales ratio for this line of products (inline and inline air walkers) from 2012 to 2016 is (b)(6).Product in house was inspected and no issues were found.The vendor was issued a supplier corrective action request (scar) for the complaint in question.If vendor investigation leads to any new findings, a follow up report will be filed.Root cause: the root cause is likely from known vendor issues that have already been corrected by the vendor.Corrective action: there is no corrective action required at this time.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

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.Detailed description of quality issue: customer said that the sole cracked in half.How was the quality issue was identified? by visual inspection.How was the product being used? therapy.Was it the initial use of the product? yes.Was the product modified from the original condition supplied by (b)(4)? no.Was the product connected to or used in conjunction with other devices or equipment? no.

• Brand Name: DEROYAL
• Type of Device: WALKING BOOT
• Manufacturer (Section D): PREMIER GUARD ZHONGSHAN LIMITED; no 52, huan mao yi road; torch development zone; zhongshan guangdong, 52840 0; CH 528400
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: elizabeth reed ; 200 debusk ln; powell 37849 ; 8653621256
• MDR Report Key: 6291355
• MDR Text Key: 66220298
• Report Number: 1060680-2017-00003
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 15540006
• Device Lot Number: 0808400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Date Manufacturer Received: 12/29/2016
• 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