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

Model Number	89-10534
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 1/6/2023 reporting hair on medium drape.A supplier corrective action request (scar) was issued to the drape supplier o&m halyard, inc.The 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.
Event or Problem Description
Hair on medium drape.
Additional Manufacturer Narrative
The sample was provided to deroyal for evaluation.A supplier corrective action request (scar) was issued to the (b)(4).Root cause: was determined by the supplier o&m halyard, inc.To be dirty area and personnel were not following good manufacturing practices.This issue was found during use, as part of the good manufacturing practices all personnel must wear cloth-like hats and antistatic gowns, additional to this cutting personnel wears gloves to avoid damage to the product.The following corrective and preventive actions have been taken by (b)(4).Internal non-conformance qnc-no3-22-00120 was created to address this issue.Create an audit commission to monitor the controlled access rules.Notified all personnel of this issue and conducted retraining on the ja-07297 procedure.Production records were reviewed, and no issues were found.An inventory check of the drape was made by deroyal, a total of 80 of the 5-5223 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 ANTERIOR SPINE 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: 16132083
• Report Number: 3005011024-2023-00001
• Device Sequence Number: 7673784
• Product Code: LRO
• UDI-Device Identifier: 00749756363532
• UDI-Public: 00749756363532
• 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
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 89-10534
• Device Catalogue Number: 89-10534
• Device Lot Number: 58074942
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/18/2023
• 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