MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL WRIST SPLINT; WRIST SPLINT, SUEDE LTHRET 8", LACE UP CLOSURE, RT, L

Model Number 23-325A-04-CFSM

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the complaint sample was not returned.The correct lot number was not listed in the complaint.No information was given about the products wear/use.Contact was made by ra to try to retrieve the complaint sample, however it has not been returned at this time.Un-released product on hand was inspected and no manufacturing defect/error was found.Root cause: investigator was unable to determine root cause as the sample was not returned.Corrections: credit was requested by user facility and issued by deroyal.Corrective action: there is no action required at this time, the complaint sample has not been returned, and no issues or defects were found in house.Preventive action: there is no action required at this time, the complaint sample has not been returned, and no issues or defects were found in house.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

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: (b)(6)-replaced this patient's large, right 8in wrist splint because the metal part was coming out and causing her pain when she would wear the brace.How was the quality issue was identified? by actual use.How was the product being used? on the hand.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 equipment? no.Outcome details: outcome(s) attributed to quality issue: none.Person(s) affected by outcome(s) checked above: none.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: patient was given a new brace.

• Brand Name: DEROYAL WRIST SPLINT
• Type of Device: WRIST SPLINT, SUEDE LTHRET 8", LACE UP CLOSURE, RT, L
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 164 giles hollow road; rose hill VA 24281
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5574832
• MDR Text Key: 43328513
• Report Number: 1123071-2016-00001
• Device Sequence Number: 1
• Product Code: ILH
• 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: 03/21/2016,04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 23-325A-04-CFSM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 03/21/2016
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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