MAUDE Adverse Event Report: SROUFE HEALTHCARE PRODUCTS DEROYAL; TENNIS ELBOW TRAP

Model Number 12840000

Device Problems Fungus in Device Environment (2316); Device Packaging Compromised (2916)

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

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Supplemental data: this product is manufactured by an outside vendor.It is also sold under to different part numbers, 12840000 and 200a10.Qc investigation: investigation findings: quality control pulled all of item 12840000 and 200a10 from the shelves at our distribution facility.Several of the units, as well as the returned sample, were covered with what appears to be mold.Other product items look like they have moisture inside the package.This issue was also found in a new shipment that had not been received (not put into the computer system) or stocked on the shelf, as well as items that had already been stocked.As a result we pulled the entire inventory for this product and destroyed it.The vendor was contacted and a scar (supplier corrective action request form) was sent for completion, along with photos of the issues found.Quality control asked the vendor if they required a sample for review, but was told "if you haven't sent the samples already please don't.We pulled our inventory and see what the issue is." per vendor instructions, our inventory of this product was destroyed.The vendor scar has not been returned at this time.Deroyal has initiated a corporate capa action point for this complaint.We will perform a health hazard assessment and determine actions for product in the field.Root cause: the vendor has not returned information regarding root cause at this time.When the scar information is returned, this call will be updated.Corrections: there was no compensation/replacement requested.Corrective action: vendor root cause/corrective and preventive action have not been returned at this time, when the scar information is returned, this call will be updated.Deroyal has initiated a corporate capa action point for this complaint.This includes a health hazard assessment to determine actions to take for product in the field.Preventive action: vendor root cause/corrective and preventive action have not been returned at this time.When the scar information is returned, this call will be updated.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? before use detailed description of quality issue: mold in packaging, unopened.How was the quality issue was identified? by visual inspection.How was the product being used? clinical setting.Used for tennis elbow.Was it the initial use of the product? yes.

Manufacturer Narrative

Date of this report was submitted on the initial medwatch as 10/19/2016.The correct date is 09/19/2016.Additional information: the vendor's scar (supplier corrective action request) was received back on 11/07/2016.Root cause: sealed packaging of the components retained environmental moisture.Lack of climate control in warehouse area.Sealed packaging of the finished goods retained environmental moisture.During container shipment, humidity and heat led to mold formation.Corrective action: raw materials for the affected item to be stored in vented packages in climate and humidity controlled area.Desiccant/vents added to finished goods packaging.Finished goods to be stored in a temperature/humidity controlled environment prior to shipment.Increased inspection upon us arrival.Preventive action: assess packaging on other items produced for deroyal items to determine if other changes are needed.Verification: periodic inspection of stored raw materials by personnel.Hundred (100%) inspection of raw materials before production.Initial 100% inspection of finished goods received at us distribution center upon receipt for next 3 orders.Increased sampling on future orders.No further information is available at this time.We will provide a follow up report if additional information becomes available.

• Brand Name: DEROYAL
• Type of Device: TENNIS ELBOW TRAP
• Manufacturer (Section D): SROUFE HEALTHCARE PRODUCTS; 961 seville road; wadsworth OH 44281
• 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: 6042190
• MDR Text Key: 57931746
• Report Number: 1060680-2016-00033
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 12840000
• Device Lot Number: 47001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• 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