MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC DEROYAL; BACK SUPPORT, PROLIGN® EXT, 25 DEGREE, BOA, M

Model Number 157-03

Device Problem Material Frayed (1262)

Patient Problem Abrasion (1689)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

Please note that even though the conclusion chosen was manufacturing deficiency.The problem was caused from a raw material used to make the brace that is purchased from an outside vendor.Investigation findings: complaint sample was received.The wires that are part of the boa fastening system were frayed (see file "figure 1 boa wire pic").Since the lot number given (30465618) the manufacturing date was traced.This was manufactured on 01/14/2013.During the time this product was for this same issue described.That the wires on the back support are fraying and have cut the patient or snagged him a few times.The wires described in the complaint are part of the (b)(4) closure system.(b)(4) is a closure system used in medical and sport devices.It is owned by (b)(4).This system is purchased from (b)(4) and used as a raw material for many of our bracing products.A supplier notification letter (snl) was issued to (b)(4) to request they investigate this problem with their wires.(b)(4) performed an investigation and found that there was a flaw in the lace (wire) obtained from their suppliers.As a result the (b)(4) representative stated to deroyal qc investigator by email the following: there was a bad batch of wires that got out to the market.Due to the small size of the issue, a formal corrective action was not filed.They had an informal communication with their wire vendor.Close inspections were implemented and no other issues had been found by them.Correction: replacement product was sent to customer.Root cause analysis: this is very likely to the vendor issue that we previously had, as the manufacturing date matches the time period when this problem occurred.Corrective action and/or systemic correction action taken: as discussed above, the vendor has already been contacted about this and they performed an investigation to solve the problem.There have been no other issues on wire fraying this year.No new action is required at this time.Preventive action: there is no preventative action needed at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

Information below was copied from complaint call text.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: the wires on back support are fraying and have cut the patient or snagged him a few times.How was the quality issue was identified? by actual use.How was the product being used? as a back brace.Was it the initial use of the product? no.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.Known pre-existing condition(s) of person(s) affected: none specified.Was the incident reported to the fda? no.Follow up questions were asked as to the level of injury.The questions and corresponding answers from the user facility are below: what part of the body were the cuts on? on patients fingers and forearms.How many cuts were there? multiple little cuts.What was the severity of the cuts? minor cuts and irritation to the forearms like a bad rash or pin pricks.Are there any pictures? no.How were these cuts treated? normal first aid treatment.Are the wires mentioned part of the boa system or is it something else? it was the wire from the boa dial that was fraying and causing irritation.

• Brand Name: DEROYAL
• Type of Device: BACK SUPPORT, PROLIGN® EXT, 25 DEGREE, BOA, M
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC; 200 debusk ln; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km7 autopista joaquin balaguer; pisano free zone, building 18; santiago, ; DR
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell, TN 37849 ; 8653621013
• MDR Report Key: 5240336
• MDR Text Key: 32261301
• Report Number: 3006851902-2015-00004
• Device Sequence Number: 1
• Product Code: IPY
• 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: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 157-03
• Device Lot Number: 30465618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2015
• Date Manufacturer Received: 10/21/2015
• 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