MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ORTHO X-RAY PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-1495
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2024 reporting surgeon found embedded wood type chips in the halyard drape.The actual sample was not available to be returned for evaluation.A photo of the drape was provided.A supplier corrective action request (scar) was issued to the drape supplier o&m halyard, inc.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.
Event or Problem Description
Surgeon found embedded wood type chips in the halyard drape.
Additional Manufacturer Narrative
A complaint was received on 11/07/2024 reporting surgeon found embedded wood type chips in the halyard drape.The product lot number was not provided, and the actual sample was not available to be returned for evaluation.A photo of the drape was provided.A supplier corrective action request (scar) was issued to the drape supplier (b)(4).(b)(4) reviewed their process for this particular foreign material reported (wooden chip,) sources inside the manufacturing line (fan fold machine) couldn't be found.The product is manufactured in the fan fold machine, where roll's raw material shrink wrap is retired, mounted and cut into spec's required length.The machine process consists uniquely in folding and stamping the material.Also, folded material bundles are shrink wrapped and, if required, tied.After machine's process, material packs are taken into transportation carts, which are covered with a transparent bag, to avoid potential contamination.During the manufacturing process, vacuum cleaners are used at any potential debris accumulated spot (such as cut material's residues, machine's wear and tear) and cotton dust mop for any particle that could be present at the area's floor.For the machine's clearance, a few liquid cleaners are applied and dried with towels.The only area in the manufacturing plant where wood is handled is in the warehouse area where there are certain raw materials that are received in wooden pallets.Potential root cause was determined by the supplier (b)(4) to be fabric rolls are transported to the machine in the control area plastic wrapped and with carton lids on both sides.There is a potential that the wood chip could have been incrusted in the plastic wrap or carton lid, and when opening this chip could have fallen in the floor and/or landed on the material and went unnoticed.Transportation carts: between the warehouse and control room there is an exchange room where material handlers load the raw materials carts used to transport the material.Potentially in that exchange room a wooden chip could potentially came incrusted into the material cartwheels and then went into the controlled room.In the control room the wooden chip came loose and could potentially ended up near the fanfold machine.For these two potential sources there are controls in place to avoid this kind of contamination which include: fabric rolls: per (b)(4) manufacturing and environmental controls, the warehouse is a #3 control manufacturing area, where corrugated cardboard and wood are allowed for high-speed lines.However, warehouse cleaning is performed per checklist form-23002 warehouse's general inspection, which assures the clean area's condition.Pallets are received with certification for optimal conditions, which means that they must not have defects, per (b)(4) nogales 3 and 5 material's incoming inspection.Pallet jacks: will be verified per (b)(4) (semiautomatic area's process and product's control).The following corrective and preventive actions have been taken by (b)(4).(b)(4) will be updated with a pallet jack's verification before the roll gets out of the exchange room.An internal non-conformance report record (qnc-no3-24-00253) was created to address no conformances due to foreign material at fan fold machine's process.Job aid ja-07317 fan fold's machine operation will be updated with an area's/floor's verification after the raw material roll's wrap is disposed, to verify that no particulate has been generated due to this task.Currently, the cleaning process is being performed based on the fan fold machine cleaning's job aid (ja-07737), which controls the contamination potential sources at the area.This job aid describes in a very detailed way the correct form to clean the machine and area.Although foreign material is not an isolated event, wood chips are.Historical complaint records were reviewed, and this is the first incident reported by deroyal related to a wooden chip.Operators must clean their workstations before starting manufacturing processes, at every shift's start and when shift's half has elapsed per job aid ja-07737 fan fold machine cleaning's job aid.An inventory check of the drape was made by deroyal, a total of 50 of the 5-5271 was 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: ORTHO X-RAY 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: 20735084
• Report Number: 3005011024-2024-00016
• Device Sequence Number: 8363113
• Product Code: LRO
• UDI-Device Identifier: 00749756214735
• UDI-Public: 00749756214735
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 89-1495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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