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

Model Number	89-10552
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Hair on back table cover.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting hair found on back table cover.The actual sample has not been returned to deroyal for evaluation at this time.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
A complaint was received on 10/19/2023 reporting hair found on back table cover.The sample was returned and evaluated.A supplier corrective action request (scar) was issued to the back table cover supplier (b)(4).(b)(4) determined a potential root cause could be related to human error for lack of follow up rules for accessing to control room.However, no actual root cause was established, due to the sample picture of hair provided being a long strand.The personnel working at the back table cover process all have short hair.Regardless of the root cause findings supplier (b)(4) notified personnel of this issue and stressed the importance of the correct gowning and the impact/risk this might have on user.The root cause for this event was unable to be determined by deroyal.There are these areas which could have contributed to hair being found within the procedure pack: possible employee failure to identify debris, possible dress code violation, lack of lab coat cleanliness, cleaning process not followed or inadequate, exposed product in warehouse, natural occurring static, and equipment has loose particulate.Per personnel dress code procedure corp.Prc.079, a mirror is placed in areas to allow employees to ensure that bouffant, beard covers and/or lab coats are applied appropriately.Personnel entering the clean manufacturing area shall perform the following steps prior to entering the room.Apply hair coverings, then next apply apparel, then if applicable apply shoe covers.Last step, wash or sanitize hands.Bouffant must cover all of hair.In order to contain all hair, more than one covering may be needed.Once a hair covering is removed, it must be discarded.Reapplication of the hair cover and beard/mustache cover must be with a new cover.Bouffant may not be worn outside of building.Brushing or combing of hair is not allowed in the changing room or any other area where products are handled or stored.Beard and/or mustache covers shall be worn in all areas that a bouffant hair covering is required and should cover all facial hair.Once removed, it must be discarded.Reapplication must be with a new cover.Lab coats are required in all clean manufacturing areas.Apparel / lab coats shall be buttoned/snapped.Apparel / lab coats shall be kept completely closed.Apparel / lab coats are not to be worn outside of the manufacturing area by manufacturing personnel.Per cleaning, sanitation and work environment procedure corp.Prc.086, machine operators shall ensure the work surface of each machine is free from dust, dirt, oil, debris and/or other foreign matter.All equipment used in production shall be cleaned.Garbage shall be removed daily as required by the respective cleaning checklist or form (do not transfer trash from one container to another).Daily - clean work area, work tables, manufacturing equipment, countertops and tables, empty trash, sweep floors and fatigue mats.The following corrective and or preventive actions have taken place by deroyal: this issue has been reviewed with the room supervisors due to employees responsible for the wrapping process for this lot 59394711 no longer work for deroyal.The dress code procedure (corp.Prc.079) is posted at the door before entering the manufacturing area.Added additional guidance to the manufacturing instructions to indicate that these products have had reports of debris to increase scrutiny during the assembly process.Production records were reviewed, and no issues were found.An inventory check of the back table cover was made by deroyal, a total of 20 of the 5-11976 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: CMC EXTREMITY 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: 18119517
• Report Number: 3005011024-2023-00034
• Device Sequence Number: 18044748
• Product Code: LRO
• UDI-Device Identifier: 00749756363549
• UDI-Public: 00749756363549
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 89-10552
• Device Lot Number: 59394711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/25/2024
• 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