MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ARTHROSCOPY PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10535
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The yellow timeout sheet has some type of grease stain on it.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting the yellow timeout sheet has some type of grease stain on it.The root cause for this event was unable to be determined.There are these areas which could have contributed to the grease being found on the timeout sheet: possible assembly slip lapse error, and possible that the label had been dropped by unknown source before it got to the manufacturing facility.The following corrective action has been taken by deroyal: manufacturing personnel were retrained on the work order process procedure acd.Qlp.034, on defective components.Per work order process procedure acd.Qlp.034, if at any time during the assembly process defective components are found, they shall be placed in the defective component bins placed on each line.At the end of the day, the defective components will be removed from the assembly area and placed in an area designated for defects.Production records were reviewed, and no issues were found.As a preventive action an inventory check of the timeout sheet was made by deroyal, a total of 80 of the 1260373 were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: ARTHROSCOPY PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 16273920
• Report Number: 3005011024-2023-00004
• Device Sequence Number: 7492820
• Product Code: LRO
• UDI-Device Identifier: 00749756363563
• UDI-Public: 00749756363563
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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 Model Number: 89-10535
• Device Catalogue Number: 89-10535
• Device Lot Number: 56631291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown