MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC DEROYAL; HEAD HALTER REPROTYPE W/ SPREADER BAR

Model Number 6114-00

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2015

Event Type  malfunction  

Event Description

Incident was reported to online retailer (b)(6), which in turn reported it to deroyal.End user reported the following: "the chin strap is held on by only one row of single stitch thread.Also 50% of the pulling weight is on chin strap.Under minimal load the chin strap failed, throwing my head and neck around violently".

Manufacturer Narrative

Investigation findings: the returned sample appears to be well worn, with damage to the stitching.Pictures are attached to complaint file show discoloration/dirtiness and material breakdown of the product.It can be seen in the pictures that the product was properly sewn.Therefore stitching damage was not caused by manufacturing error.The stitching damage allowed the webbing to pull away from the body of the product.Correction: credit requested.Root cause analysis: no manufacturing defect was found.The chin strap issue is related to stitching damage not to manufacturing error.Corrective action and/or systemic correction action taken: no action taken, no manufacturing defect was found.

• Brand Name: DEROYAL
• Type of Device: HEAD HALTER REPROTYPE W/ SPREADER BAR
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC; knoxville TN
• Manufacturer Contact: 200 debusk ln; knoxville, TN 37849 ; 8653621013
• MDR Report Key: 4729928
• MDR Text Key: 16309787
• Report Number: 1123071-2015-00003
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6114-00
• Device Catalogue Number: 01320
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2015
• Event Location: Home
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/24/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other